Tuesday, July 1, 2014

July Update: Sofosbuvir Based Hepatitis C Clincial Trials

The hepatitis C clinical trials on this page are not a complete list; to learn more about HCV trials or to find out if a study is enrolling patients in your area, please click  here. View additional hepatitis trials updated in the last 30 days @ ClinicalTrials.gov

United States
Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis (VALOR-HCV) 

This study is currently recruiting participants 

Verified June 2014 by Gilead Sciences
Information provided by (Responsible Party): Gilead Sciences 

Purpose
This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.

Condition Intervention Phase
Hepatitis C Virus Infection Drug: Sofosbuvir
Drug: RBV
Phase 4

ClinicalTrials.gov Identifier:NCT02128542
Contact: Gilead Study Team GS3341379study@gilead.com

First received: April 29, 2014
Last updated: June 9, 2014
Last verified: June 2014
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India

Purpose
 This is a multi-center, randomized, open-label study to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir+ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or genotype 3 hepatitis C virus (HCV) infection.
 
Condition Intervention Phase
Chronic HCV Infection Drug: Sofosbuvir
Drug: RBV
Phase 3

ClinicalTrials.gov Identifier:NCT02074514 
Contact: Gilead Study Team gs3340116study@gilead.com

First received: February 26, 2014

Last updated: June 27, 2014
Last verified: June 2014
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Not Yet Recruiting

United States, Australia, Germany, Italy, New Zealand, Russian Federation 
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

This study is not yet open for participant recruitment. 

Verified June 2014 by Gilead Sciences
Sponsor:  Gilead Sciences
Information provided by (Responsible Party): Gilead Sciences

Purpose 
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.
The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.

Condition Intervention Phase
Hepatitis C Virus InfectionDrug: SOF
Drug: RBV
Phase 2

ClinicalTrials.gov Identifier: NCT02175758
Contact: Gilead Study Team 334-1112alerts@gilead.com

First received: June 24, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
Click here to learn more
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Contact and Locations Not Provided
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4) 

This study is not yet open for participant recruitment

Verified June 2014 by Bristol-Myers Squibb
Information provided by (Responsible Party): Bristol-Myers Squibb 

Purpose
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Condition Intervention Phase
Hepatitis C VirusDrug: DCV/ASV/BMS-791325Phase 3

ClinicalTrials.gov Identifier: NCT02170727
Contact and Locations Not Provided

First received: June 20, 2014
Last verified: June 2014
History: No changes posted 
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Contact and Locations Not Provided
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

This study is not yet open for participant recruitment. 

Verified June 2014 by Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb 

Purpose
The purpose of the study is to determine whether the combination of Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
Condition Intervention Phase
Hepatitis CDrug: DCV/ASV/BMS-791325
Drug: Ribavirin
Drug: Sofosbuvir
Drug: Peginterferon α-2a
Phase 2

ClinicalTrials.gov Identifier: NCT02175966
Contact and Locations Not Provided

First received: June 25, 2014
Last verified: June 2014
History: No changes posted
Click here to learn more..... 
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For additional information visit HCV Advocate News and Pipeline for trial updates;





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