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Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin

NCT01995266•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
•Males and females, ≥ 18 years of age
•Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
•1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
•or
•2. Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
•Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
•1. Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to \< 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin \< 10.0 g/dL and ≥ 8.5 g/dL
•OR
•2. Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to \< 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC \< 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L
+6 more criteria

Exclusion Criteria

•Prior treatment with HCV direct acting antiviral (DAA)
•Evidence of a medical condition contributing to chronic liver disease other than HCV
•Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
•Diagnosed or suspected hepatocellular carcinoma or other malignancies
•Uncontrolled diabetes or hypertension
•History of moderate to severe depression. Well-controlled mild depression is allowed
•Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
•Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN)
•Confirmed albumin \< 3.5 g/dL (35 g/L)
•Alpha-fetoprotein (AFP) \> 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded
+3 more criteria

Locations (38)

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Guangdong, China

Local Institution

Chongqing, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Wuhan, Hubei, China

Key Dates

Start Date

February 28, 2014

Primary Completion Date

July 31, 2015

Completion Date

July 31, 2015

Last Updated

August 11, 2020

Enrollment

218

ACTUAL participants

Conditions

Hepatitis C

Interventions

Asunaprevir

DRUG

Daclatasvir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Inclusion Criteria

Exclusion Criteria

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