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Results 21 - 30 of 635

A Phase 3, randomized, stratified, observer-blind, active-controlled study to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults 18 years and older

Recruitment Status
Pending
Project Status
Ongoing
Project Description

This is a Phase 3, randomized, stratified, observer-blind, active-controlled study to evaluate the immunogenicity and safety of mRNA-1010 vaccine in preventing seasonal influenza in adults aged 18 years and older.

Primary Sponsor
ModernaTX, Inc.
Study Type
Interventional
Date of Registration
27 July 2022
Date of FIrst Enrollment
30 November -0001
Region
United Kingdom
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0681
Sources of Monetary or Material Support
ModernaTX, Inc.
Primary Outcomes
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ] Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay [ Time Frame: Day 29 ] . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures. For female participants of childbearing potential: negative pregnancy test, adequate con . . .
Countries of Recruitment
Argentina, Australia, Colombia, Panama, Philippines
Health Condition(s) or Problem(s) Studied

Seasonal influenza


A Global Study to Assess the Effects of Durvalumab +Domvanalimab Following Concurrent Chemoradiation in Patients with Stage III Unresectable Non-Small Cell LungCancer (PACIFIC 8)

Recruitment Status
Pending
Project Status
Pending
Project Description
This is a Phase III, parallel, randomised, double-blind, placebo-controlled,2-arm,multicentre, international study assessing the efficacy and safety of durvalumab plus domvanalimabin participants with locally advanced(Stage III), unresectable NSCLC whose disease has not progressed following defin . . .
Primary Sponsor
AstraZeneca Pharmaceuticals (Philippines) Inc.
Secondary Sponsor
NA
Study Type
Interventional
Date of Registration
02 June 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2022-CT0668
Sources of Monetary or Material Support
AstraZeneca AB
Primary Outcomes

PFS is defined as time from randomisation until progression per RECIST1.1 as assessed by BICR, or death due to any cause

•PFS measured by HR

Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Participant must be ≥18 years at the time of screening. 2. Participants must have histologically or cytologically documented NSCLC and have been treated with concurrent CRT for locally adva . . .
Health Condition(s) or Problem(s) Studied

Locally advanced (Stage III), unresectable Non-small cell lung cancer


A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a Phase 2b, randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy, safety, and PK of TPIP in participants diagnosed with PAH. This is the first placebo-controlled study of TPIP in participants with PAH. For individual participants, the st . . .
Primary Sponsor
Insmed Incorporated
Secondary Sponsor
PPD Pharmaceutical Development Philippines Corporation
Study Type
Interventional
Date of Registration
21 May 2022
Date of FIrst Enrollment
15 August 2022
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2022-CT0674
Sources of Monetary or Material Support
Insmed Incorporated
Primary Outcomes

Primary:

  • To assess the effect of TPIP compared with placebo on PVR

 

Key Inclusion and Exclusion Criteria
Inclusion Criteria Participants are eligible to be included in the study only if all the following criteria apply: Age Participants must be ≥ 18 to ≤ 75 years at the time of signing the ICF. Participants in Japan must b . . .
Countries of Recruitment
Argentina, Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Pulmonary Arterial Hypertension (PAH)


INNOVATE- Inovio INO-4800 Vaccine Trial for Efficacy

Recruitment Status
Pending
Project Status
Terminated
Project Description
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 in participants at high risk of exp . . .
Primary Sponsor
Inovio Pharmaceuticals, Inc.
Study Type
Interventional
Date of Registration
11 September 2021
Date of FIrst Enrollment
30 November -0001
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0626
Sources of Monetary or Material Support
Advaccine Biopharmaceuticals
Inovio Pharmaceuticals, Inc.
Primary Outcomes
Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay   [Time Frame: Baseline up to Day 393] Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovi . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings. Phase 2 only: Scree . . .
Countries of Recruitment
Brazil, Mexico, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

COVID-19 Disease


Safety and Pharmacodynamics of Repeat Doses of ANX009 SC in Participants with Lupus Nephritis

Recruitment Status
Pending
Project Status
Pending
Project Description
This study is a Phase 1b, nonrandomized, open-label, single-arm study to assess the safety, tolerability, and PD of repeat doses of ANX009 administered by SC infusion to participants with LN. Participants in the study are able to continue to receive stable background standard of care therapy for . . .
Primary Sponsor
ICON Clinical Research Services Inc.
Secondary Sponsor
St. Luke's Medical Center - Quezon City
Study Type
Interventional
Date of Registration
15 March 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Single
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2022-CT0663
Sources of Monetary or Material Support
Annexon, Inc.
Inovio Pharmaceuticals, Inc.
Primary Outcomes

Primary Endpoint : Number and percentage of participants with treatment-emergent adverse events (TEAEs)

Key Inclusion and Exclusion Criteria
Inclusion Criteria Age Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to ≤75 years of age inclusive, at the time of signing the informed consent. Type of . . .
Countries of Recruitment
Philippines, Taiwan, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Men and women aged 18 to75 years old who have been diagnosed with Lupus Nephritis


Safety and immunogenicity of Recombinant COVID-19 vaccine  as a booster following primary vaccination of either Inactivated or mRNA or Viral Vector COVID-19 vaccines: A phase II observer-blind, randomized, controlled, investigator-initiated clinical trial

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase II observer-blind randomized controlled trial to evaluate the safety and immunogenicity of Recombinant COVID-19 vaccine  (SF9 cells) booster vaccination following primary vaccination of either Inactivated or mRNA or Viral Vector COVID-19 vaccines produce . . .
Primary Sponsor
WestVac Biopharma Co., Ltd.
Study Type
Interventional
Date of Registration
20 June 2022
Date of FIrst Enrollment
30 November -0001
Region
China
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2022-CT0671
Sources of Monetary or Material Support
WestVac Biopharma Co., Ltd.
Inovio Pharmaceuticals, Inc.
Primary Outcomes
Primary endpoints Safety Incidence of adverse drug reactions (ADRs) 0 to 28 days after a booster dose. Immunogenicity Geometric mean titer (GMT) of specific neutralizing antibody (Virus or Pseudovirus Neutralizatio . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria Participant is willing and able to give written informed consent for participation in the trial. Male or Female, aged 18 years or . . .
Countries of Recruitment
Philippines, Taiwan, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Prevention of COVID-19 caused by infection with the SARS-CoV-2.


Mindfulness-Based Self-Compassion Therapy as an Adjunct Treatment for Moderate to Severe Chronic Plaque Psoriasis: A Randomized Control Trial

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Purpose of the researchReducing stress through mindfulness may lead to improvement of the skin lesions in psoriasis. The results of the study may benefit patients by providing patients with alternatives that have long-term effects as compared to the known standard treatments. The results of . . .
Primary Sponsor
Rizal Medical Center Department of Dermatology
Study Type
Interventional
Date of Registration
21 June 2022
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Randomized
Masking
Single Blind
Assignment
Single
Phase
Phase 0
Sources of Monetary or Material Support
Rizal Medical Center Department of Dermatology
Inovio Pharmaceuticals, Inc.
Primary Outcomes

Psoriasis Area Severity Index

Dermatology Life Quality Index

Key Inclusion and Exclusion Criteria
The inclusion criteria will be age 19 years and above who understands and can comprehend the English language with a clinical diagnosis of moderate to severe chronic plaque psoriasis based on PASI or DLQI (PASI >10 or DLQI >10) that are undergoing combination therapy of topical and s . . .
Countries of Recruitment
Philippines, Taiwan, Philippines, Belgium, Brazil, Denmark, France, Germany, Italy, Japan, Malaysia, Mexico, Peru, Philippines, Serbia, Spain, Switzerland, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Chronic Plaque Psoriasis


A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This open label, non-randomised multi-regimen, 5-year extension study investigates the long-term safety and efficacy of BI 655130 in patients (adult and adolescent) with Generalized Pustular Psoriasis (GPP) who have completed their participation in previous BI 655130 trials 1368-0013 or 1368-0027 . . .
Primary Sponsor
Boehringer Ingelheim (Philippines), Inc.
Secondary Sponsor
PAREXEL Clinical Research (Philippines) Ltd. Corp.
Study Type
Interventional
Date of Registration
25 November 2021
Date of FIrst Enrollment
30 November -0001
Region
NCR
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2021-CT0644
Sources of Monetary or Material Support
Boehringer Ingelheim Singapore, Pte. Ltd.
Inovio Pharmaceuticals, Inc.
Primary Outcomes

Primary objective: to evaluate the long-term safety and efficacy of BI 655130 in patients with GPP, who have completed previous BI 655130 trials

Primary endpoint: occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment.

Key Inclusion and Exclusion Criteria
Inclusion criteria: 1. Male of female patients who have completed the treatment period without premature discontinuation in the previous BI 655130 trial (1368-0013 or 1368-0027) and are willing and able to continue treatment in the current trial. 2. Women of childbearing potential . . .
Countries of Recruitment
Argentina, Belgium, Chile, China, France, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Generalized Pustular Psoriasis (GPP)


A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric Sprotein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, who Previously Received Primary Series of a COVID-19 Vaccine

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is a multi-center, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity and safety of SCB-2019 vaccine administered as a booster dose in individuals who received primary vaccination series with one of the selected COVID-19 vaccines, ≥3months prior to enrollme . . .
Primary Sponsor
Clover Biopharmaceuticals AUS Pty Ltd
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
11 July 2022
Date of FIrst Enrollment
13 June 2022
Region
None
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
'20220315145097
Sources of Monetary or Material Support
Clover Biopharmaceuticals AUS Pty Ltd
Inovio Pharmaceuticals, Inc.
Primary Outcomes

The primary endpoints are SARS-CoV-2-neutralization titers at Day 15 in SCB-2019 booster recipients and recipients of a homologous booster vaccine within each primary vaccination group (Comirnaty,
COVID-19 Vaccine Janssen, and CoronaVac).

Key Inclusion and Exclusion Criteria
Inclusion CriteriaParticipants are eligible to be included in the study only if all of the following criteria apply:1. Male or female participants ≥18 years of age.2. Individuals willing and able to comply with study requirements, including all scheduled visit . . .
Countries of Recruitment
Philippines, Belgium, Chile, China, France, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey, United States, Vietnam
Health Condition(s) or Problem(s) Studied

COVID 19


Effectiveness of Simplified Negative Wound Pressure Therapy in Wound Healing of Diabetic Foot Ulcers: A Randomized Control Study.

Recruitment Status
Pending
Project Status
Pending
Project Description
             Foot disorders such as ulcerations, infection and gangrene are myriad of complications of diabetes mellitus which is also the leading cause of surgical management among patients suffering from diabetic foot. Negative pressure wound therapy has been an increasing trend as . . .
Primary Sponsor
Southern Phiippines Medical Center
Secondary Sponsor
Southern Phiippines Medical Center
Study Type
Interventional
Date of Registration
16 May 2022
Date of FIrst Enrollment
30 November -0001
Region
Region XI
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Not Applicable
Sources of Monetary or Material Support
Southern Philiipines Medical Center
Inovio Pharmaceuticals, Inc.
Primary Outcomes

Wound healing

Key Inclusion and Exclusion Criteria
Inclusion criteria: Adult diabetic patients 18 years old and above with diabetic foot ulcer admitted in SPMC orthopedics ward were included in the study. Diabetic foot ulcers classified as Texas diabetic wound classification II (A,B,C,D). All pa . . .
Countries of Recruitment
Philippines, Belgium, Chile, China, France, Germany, Italy, Japan, Malaysia, Mexico, Philippines, Russia, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey, United States, Vietnam
Health Condition(s) or Problem(s) Studied

Diabetic foot ulcers


Results 21 - 30 of 635
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