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Results 41 - 50 of 635

A randomized, parallel-group, double-blind, placebo-controlled, multicenter phase III study to investigate the efficacy and safety of secukinumab (Cosentyx®) 300 mg administered subcutaneously in patients with active peripheral spondyloarthritis (pSpA)

Recruitment Status
Pending
Project Status
Pending
Project Description
The purpose of this Phase III study is to investigate the efficacy and safety of the IL-17A inhibitor secukinumab 300 mg in participants with two subtypes of active pSpA i.e. undifferentiated pSpA and chronic reactive arthritis, and with an inadequate response toconventional therapy despite . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
03 February 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0654
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
The primary analysis will be conducted via logistic regression with treatment, gender and stratification variable (undifferentiated pSpA vs. chronic reactive arthritis) and baseline CRPstatus (elevated vs. normal) as factors, and baseline weight as a covariate as appropriate. Difference in . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Participant meets ASAS criteria for classification of pSpA:· Participant must have current arthritis (asymmetric or predominantly in the lower limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) . . .
Health Condition(s) or Problem(s) Studied

With active peripheral spondyloarthritis (pSpA)

TH HBV ASO-001

Recruitment Status
Pending
Project Status
Ongoing
Project Description
GlaxoSmithKline Biologicals SA (GSK) is developing new chronic Hepatitis B (CHB) targeted immunotherapy (TI) strategies with the aim of inducing robust T-cell response and/or antibody response against different Hepatitis B virus (HBV) antigens to restore the immune control of HBV infection and ul . . .
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Interventional
Date of Registration
26 January 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Single
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0650
Sources of Monetary or Material Support
GlaxoSmithKline Biologicals
Primary Outcomes
Safety• Percentage of participants reporting any grade 3 AE from first dose of GSK3228836 up to the study end• Percentage of participants reporting any SAE from first dose of GSK3228836 up to the study end• Percentage of participants reporting any grade 3 . . .
Key Inclusion and Exclusion Criteria
Male or female between, 18 and 65 years of age at the time of signing of the informed consent. HBeAg positive or negative Participants who have documented chronic HBV infection ≥6 months prior to screening and currently receiving stable NA therapy population defined a . . .
Countries of Recruitment
Belgium, Bulgaria, France, Germany, Hong Kong, Italy, Philippines, Poland, Romania, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom
Health Condition(s) or Problem(s) Studied

chronic Hepatitis B (CHB)

EVALUATION OF Senna (Cassia) alata (Linn) Roxb. LEAF TOPICAL SOLUTION VERSUS KETOCONAZOLE 2% AS TREATMENT FOR SCALP SEBORRHEIC DERMATITIS

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description

A randomized control trial aimed to determine the efficacy of cassia alata topica solution compared to ketoconazole 2% shampoo for the treatment of scalp seborrheic dermatitis

Primary Sponsor
Southern Philippines Medical Center, Davao City, Philippines
Secondary Sponsor
Southern Philippines Medical Center, Davao City, Philippines
Study Type
Interventional
Date of Registration
15 March 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Not Applicable
Phase
Phase 0
Sources of Monetary or Material Support
Southern Philippines Medical Center, Davao City, Philippines
Primary Outcomes
  • Erythema, desquamation, total area scores using a four-point scale
  • Clinical severity score 
  • Pruritus score
  • Subjective improvement 
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Female/Male patients 18-60 years old with clinically diagnosed scalp seborrheic dermatitis Wash-out period of at least 2 weeks for topical treatment, 1 month for oral treatment Participants willing to undergo photo-documentat . . .
Health Condition(s) or Problem(s) Studied

Scalp seborrheic Dermatitis 

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Recruitment Status
Pending
Project Status
Ongoing
Project Description

A global, randomized phase III study to evaluate perioperative pembrolizumab or pembrolizumab plus enfortumab vedotin with radical cystectomy + pelvic lymph node dissection (RC+PLND) versus RC+PLND alone in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC).

Primary Sponsor
Merck Sharp & Dohme (I.A.) LLC
Study Type
Interventional
Date of Registration
11 September 2021
Date of FIrst Enrollment
17 January 2022
Region
NCR
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0593
Sources of Monetary or Material Support
Merck Sharp & Dohme (I.A.) LLC
Primary Outcomes
1. Pathologic Complete Response (pCR) Rate [ Time Frame: Up to approximately 5.7 years ]Pathologic complete response rate is defined as the percentage of participants having pCR. pCR is defined as absence of viable tumor (pT0N0) in examined tissue from RC and PLND, as determined centrally. . . .
Key Inclusion and Exclusion Criteria
1. Have a histologically confirmed diagnosis of urothelial carcinoma (cT2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%) urothelial histology to be confirmed by Blinded Independent Central Review (BICR) (central pathology and/or imaging). 2. Clinically nonmetastatic bladder cancer deter . . .
Countries of Recruitment
Australia, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Urinary Bladder Cancer, Muscle-invasive

EFFECTIVENESS AND SAFETY OF SOYBEAN 4% OINTMENT VERSUS CLOBETASOL PROPIONATE 0.05% OINTMENT IN MILD PLAQUE  PSORIASIS (BSA <3%): A RANDOMIZED CLINICAL TRIAL

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description

A randomized, double-blind clinical trrial on the efficacy and safety of soybean 4% ointment versus clobetasol propionate 0.05% ointment in mild plaque psoriasis (BSA <3%) at the Southern Philippines Medical Center.

Primary Sponsor
Southern Philippines Medical Center
Study Type
Interventional
Date of Registration
28 February 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Self funded
Primary Outcomes

Clinical remission using the PASI 90 response or ≥ 90% improvement in Psoriasis Area and Severity Index

Key Inclusion and Exclusion Criteria
Inclusion Criteria: Participants aged 18 years old and above diagnosed clinically with mild plaque psoriasis according to the Body Surface Area classification (<3%). Participants previously on topical psoriasis therapy who have completed a two-week was . . .
Countries of Recruitment
Philippines, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Mild plaque psoriasis (BSA <3%)

A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ligelizumab (QGE031) in the treatment of Chronic Inducible Urticaria (CINDU) in adolescents and adults inadequately controlled with H1-antihistamines

Recruitment Status
Pending
Project Status
Pending
Project Description

This is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study. There is a screening period of up to 28 days, a 24 week double-blind treatment period, and a 12 week post-treatment follow-up period.

Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
11 February 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0648
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes
The primary objective of this study is to demonstrate superiority of ligelizumab versus placebo with regards to the change from baseline in response to standardized provocation test at week 12 for each CINDU subtype. For each subtype of CINDU, the primary clinical question of interest is what the . . .
Key Inclusion and Exclusion Criteria
History of hypersensitivity to any of the study drugs or its components or to drugs of similar classes (i.e. to murine, chimeric or human antibodies) or to the provocation test or items used in provocation tests Participants who have concomitant C . . .
Countries of Recruitment
Philippines, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Chronic Inducible Urticaria (CINDU)

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

Recruitment Status
Pending
Project Status
Pending
Project Description

This study is a Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study, and aim to to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy in treating of Paroxysmal Nocturnal Hemoglobinuria

Primary Sponsor
BioCryst Pharmaceuticas
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
12 November 2021
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0634
Sources of Monetary or Material Support
BioCryst Pharmaceutical
Primary Outcomes
Part 1 Primary Endpoint:• Change from baseline (CFB) in hemoglobin (Hb) [at Week 12] Part 2 Primary Endpoints• Number and proportion of subjects with a TEAE • Number and proportion of subjects who discontinue due to a TEAE• Number and proportion of subjects . . .
Key Inclusion and Exclusion Criteria
Diagnosis and Main Criteria for Inclusion:Subjects must meet all of the following criteria, as applicable, to be eligible for participation in this study:1. Male or female, aged ≥ 18 years old.2. Body weight ≥ 40 kg.3. Documented diagnosis of PNH confirmed by flow cyto . . .
Countries of Recruitment
Philippines, Belgium, Canada, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Paroxysmal Nocturnal Hemoglobinuria

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intranasal INNA-051 for Prevention of COVID-19 in Adults Following Close Contact With Individuals With SARS-CoV-2 Infection

Recruitment Status
Withdrawn
Project Status
Terminated
Project Description
This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in adult participants following household contact with an individual with RT-PCR-confirmed SARS-CoV-2 infection. This study will evaluate 2 active dose levels (150 μg and 300 μg) of INNA-051 and placebo. The study . . .
Primary Sponsor
Ena Respiratory Pty Ltd
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Study Type
Interventional
Date of Registration
01 March 2022
Date of FIrst Enrollment
30 November -0001
Region
None
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0655
Sources of Monetary or Material Support
Ena Respiratory Pty Ltd
Primary Outcomes
  • Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR-confirmed SARS-CoV-2 infection.
  • Evaluate the safety and tolerability of INNA-051.
Key Inclusion and Exclusion Criteria
Each participant must meet all the following criteria to be enrolled in this study: Capable of understanding the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements. Male or female aged ≥18 years. . . .
Countries of Recruitment
Mexico, Philippines, South Africa, Ukraine, Vietnam, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Thailand, Turkey, Ukraine, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

SARS-CoV-2 infection

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

Recruitment Status
Pending
Project Status
Pending
Project Description
This study aims to confirm that the previous treatment regimens with GSK3228836 can lead to long-term sustained loss of HBsAg by conducting long-term follow-up of treatment naïve and nucleos(t)ide analogue (NA) controlled CHB participants who have previously received GSK3228836 in a treatment/in . . .
Primary Sponsor
GlaxoSmithKline Research & Development Limited (UK)
Secondary Sponsor
Makati Medical Center
Study Type
Observational
Date of Registration
16 November 2021
Date of FIrst Enrollment
30 November -0001
Region
United Kingdom
Method of Allocation
Randomized
Masking
N/A
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0645
Sources of Monetary or Material Support
GlaxoSmithKline Research & Development Limited (UK)
Primary Outcomes
• Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication). •  Time from NA cessation to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion . . .
Key Inclusion and Exclusion Criteria
INCLUSION CRITERIA Participants who have previously received at least one dose of GSK3228836 AND                                                                                                                            . . .
Health Condition(s) or Problem(s) Studied

Chronic Hepatitis B Participants

A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease

Recruitment Status
Pending
Project Status
Pending
Project Description
CKJX839812302 is a randomized, double-blind, parallel group, placebo controlled, multi-center, event-driven study evaluating inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants with established ASCVD as evidenced by history of myoca . . .
Primary Sponsor
Novartis Healthcare Philippines, Inc.
Study Type
Interventional
Date of Registration
22 November 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0640
Sources of Monetary or Material Support
Novartis Healthcare Philippines, Inc.
Primary Outcomes

The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C ≥1.8 mmol/L(70 mg/dL)

Key Inclusion and Exclusion Criteria
   Participants eligible for inclusion in this study must fulfill all of the following criteria: Male or female 240 years of age Fasting LDL-C ≥1.8 mmol/L (70 mg/dL) at the Screening Visit At the Screening Visit, participants must be on a stable (24 . . .
Health Condition(s) or Problem(s) Studied

Cardiovascular disease

Results 41 - 50 of 635
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