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NCT02219477 Clinical Trial

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis

Chronic Hepatitis C Clinical Trial

— TURQUOISE-CPB  

Official title:
An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02219477
Other study ID # M14-227
Secondary ID 2014-001477-13
Status Completed
Phase Phase 3
First received August 15, 2014
Last updated March 7, 2017
Start date November 2014
Est. completion date March 2017

Study information
Verified date March 2017
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with Ribavirin in Adults with Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date March 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

1. HCV Genotype 1(GT1)- or Genotype 4 (GT4)-infection defined as: Positive for anti-HCV Ab, HCV RNA > 1,000 IU/mL and laboratory result indicating HCV GT1 infection at Screening.

2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., CT or MRI).

3. Child-Pugh Score 7 - 9 inclusive at time of Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).

3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon/RBV and/or pegylated interferon (pegIFN)/RBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).

4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).

5. Any current or past evidence of Child-Pugh C classification.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-450/ritonavir/ABT-267
tablet
• ABT-333
tablet
• Ribavirin
tablet

Locations
Country Name City State
Canada Site Reference ID/Investigator# 127626 Calgary
Canada Site Reference ID/Investigator# 127628 Toronto
Canada Site Reference ID/Investigator# 127627 Vancouver
Canada Site Reference ID/Investigator# 127629 Vancouver
Germany Site Reference ID/Investigator# 137264 Berlin
Germany Site Reference ID/Investigator# 127541 Frankfurt
Germany Site Reference ID/Investigator# 127542 Leipzig
United States Site Reference ID/Investigator# 127578 Aurora Colorado
United States Site Reference ID/Investigator# 127580 Charlotte North Carolina
United States Site Reference ID/Investigator# 127740 Dallas Texas
United States Site Reference ID/Investigator# 128358 Detroit Michigan
United States Site Reference ID/Investigator# 127577 New Orleans Louisiana
United States Site Reference ID/Investigator# 127582 Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants with Sustained Virologic Response 12 weeks post-treatment Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) less than the lower limit of quantification 12 weeks after the last actual dose of study drug
Secondary Percentage of participants with virologic failure during treatment The percentage of subjects with confirmed, quantifiable HCV RNA among subjects with previous unquantifiable HCV RNA during treatment Up to 24 weeks while on treatment followed by 48 weeks after last actual dose of study drug
Secondary Percentage of participants with virologic relapse post-treatment The percentage of subjects with confirmed, quantifiable HCV RNA among subjects with previous unquantifiable HCV RNA at the end of treatment Up to 48 weeks after the last actual dose of study drug
Secondary Percentage of participants with improvement in laboratory parameters associated with hepatic function It will indicate improvement or worsening and percentage of subjects with improvement will be presented for each of the hepatic function laboratory parameters. Up to Post-treatment Week 12
Secondary Percentage of Genotype 4 participants with Sustained Virologic Response 12 weeks post-treatment Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) less than the lower limit of quantification 12 weeks after the last actual dose of study drug
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