A Study to Evaluate Chronic Hepatitis C Infection in Cirrhotic Adults With Genotype 1b Infection

Chronic Hepatitis C Infection Clinical Trial

— Turquoise-IV  

Official title:

An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216422
• Other study ID #: M14-252
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2014
• Last updated: January 20, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationUnited States: Food and Drug AdministrationBelarus: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A study to evaluate chronic hepatitis C infection in cirrhotic adults with genotype 1b infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)

• evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening

• Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control

Exclusion Criteria:

• Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody

• evidence of current or past Child-Pugh B or C classification

• confirmed presence of hepatocellular carcinoma

• abnormal laboratory tests

• self-reports current drinking more than 2 drinks per day

• previous treatment with a direct acting antiviral agent (DAA) containing regimen

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• ABT-450/r/ABT-267
Tablet
• ABT-333
Tablet
• Ribavirin (RBV)
Tablet

Locations

Country	Name	City	State
Belarus	Site Reference ID/Investigator# 129376	Minsk
Russian Federation	Site Reference ID/Investigator# 127302	Moscow
Russian Federation	Site Reference ID/Investigator# 127305	Moscow
Russian Federation	Site Reference ID/Investigator# 127306	Moscow
Russian Federation	Site Reference ID/Investigator# 128341	Moscow
Russian Federation	Site Reference ID/Investigator# 128342	Moscow
Russian Federation	Site Reference ID/Investigator# 127303	Stavropol

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Belarus,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with sustained virologic response 12 weeks post-treatment	Hepatitis C Virus ribonucleic acid less than the lower limit of quantification	12 weeks after the last dose of study drug	No
Secondary	Percentage of subjects with virologic failure during treatment	Hepatitis C Virus ribonucleic acid greater than the lower limit of quantification	Up to Week 12	No
Secondary	Percentage of subjects with virologic relapse after treatment	Hepatitis C virus ribonucleic acid greater than the lower limit of quantification	Up to post-treatment Week 24	No