Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis C
  3. NCT02219477
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03673696 - The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects Phase 1
Completed NCT02250001 - Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C N/A
Completed NCT03088917 - 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02865369 - Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment N/A
Recruiting NCT02638233 - Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy Phase 4
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Not yet recruiting NCT01949168 - A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV Phase 2
Completed NCT02788682 - Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy N/A
Completed NCT01439776 - Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients Phase 4
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A
Completed NCT00968357 - Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed Phase 2
Terminated NCT00962936 - Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection Phase 1/Phase 2
Recruiting NCT01178749 - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments N/A
Recruiting NCT00575627 - Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels Phase 4
Completed NCT00537407 - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment Phase 2
Recruiting NCT00370617 - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance Phase 4
Completed NCT01684787 - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients Phase 4