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
Sponsor: Gilead Sciences
Information provided by (Responsible Party): Gilead Sciences
Purpose
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
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
This study is currently recruiting participants
This study is currently recruiting participants
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
-------------------------------------------------------------------------------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 Infection | Drug: 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
Sponsor: Bristol-Myers Squibb
Information provided by (Responsible Party): Bristol-Myers Squibb
Purpose
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 Virus | Drug: DCV/ASV/BMS-791325 | Phase 3 |
ClinicalTrials.gov Identifier: NCT02170727
Contact and Locations Not Provided
First received: June 20, 2014
Last verified: June 2014
History: No changes posted
------------------------------------------------------------------------------- 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
Verified June 2014 by Bristol-Myers Squibb
Sponsor: Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
Purpose
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 C | Drug: 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;
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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