- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646111
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures
An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure
The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.
The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.
At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:
- Group A - genotype 1b without cirrhosis - 12 weeks of treatment *
- Group B - genotype 1b with cirrhosis - 12 weeks of treatment
- Group C - genotype 1a without cirrhosis - 12 weeks of treatment
- Group D - genotype 1a with cirrhosis - 24 weeks of treatment
(* Only this group will not get Ribavirin)
During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.
The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of hepatitis C, genotype 1A or 1B.
- Documentation of PI failure of treatment at least 12 months prior to study entry.
- Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).
Exclusion Criteria:
- Inability to stay in the study for 36 weeks.
- Diagnosis of cross-contamination by HIV or Hepatitis B virus.
- Renal disfunction (creatinine clearance <30 ml / min).
- Evidence of hepatic carcinoma.
- Another serious disease, which may interfere with the study.
- Pregnant / breast-feeding women.
- Men with pregnant partners.
- Drug or alcohol abuse in the six months preceding the study.
- Chronic liver disease other than hepatitis C (such as Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis).
- Current other treatment for HCV.
- Past PI Failure due to adverse events.
- Patients with cirrhosis Child B.
- Patients with cirrhosis, who were at child B and improved to child A after treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Genotype 1b without cirrhosis
12 weeks without Ribavirin
|
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.
Other Names:
|
Experimental: Genotype 1b with cirrhosis
12 weeks with Ribavirin
|
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
Other Names:
|
Experimental: Genotype 1a without cirrhosis
12 weeks with Ribavirin
|
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
Other Names:
|
Experimental: Genotype 1a with cirrhosis
24 weeks with Ribavirin
|
24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"SVR" (sustained virologic response) rates
Time Frame: 12 weeks after end of treatment
|
Sustained virologic response
|
12 weeks after end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"SF" (short-form)-36 health survey
Time Frame: Day 1, weeks 4, 12, 24, 36.
|
psychometrically-based physical and mental health and a preference-based health utility index.
|
Day 1, weeks 4, 12, 24, 36.
|
WPAI Hep C v2.0 questionnaire
Time Frame: Day 1, weeks 4, 12, 24, 36.
|
a scoring manual for work productivity and activity impairment assessment.
|
Day 1, weeks 4, 12, 24, 36.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- TASMC-15-OS-503-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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