Chronic Hepatitis C Clinical Trial
— TURQUOISE-CPBOfficial 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)
Verified date | March 2017 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
United States, Canada, Germany,
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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