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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646111
Enrollment
120
Registered
2016-01-05
Start date
2016-01-31
Completion date
2019-01-31
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C Virus, Triple Therapy, PI Failure, Genotype 1

Brief summary

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.

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.

Interventions

DRUG12 weeks without Ribavirin

12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.

DRUG12 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.

DRUG24 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.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SVR (sustained virologic response) rates12 weeks after end of treatmentSustained virologic response

Secondary

MeasureTime frameDescription
SF (short-form)-36 health surveyDay 1, weeks 4, 12, 24, 36.psychometrically-based physical and mental health and a preference-based health utility index.
WPAI Hep C v2.0 questionnaireDay 1, weeks 4, 12, 24, 36.a scoring manual for work productivity and activity impairment assessment.

Contacts

Primary ContactOren Shibolet, MD
orensh@tlvmc.gov.il97236973984

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026