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Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures

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ClinicalTrials.gov Identifier: NCT02646111
Recruitment Status : Unknown
Verified January 2016 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE December 28, 2015
First Posted Date  ICMJE January 5, 2016
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
"SVR" (sustained virologic response) rates [ Time Frame: 12 weeks after end of treatment ]
Sustained virologic response
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • "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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: 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 Name: Triple therapy
  • Drug: 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 Name: Triple therapy
  • Drug: 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 Name: Triple therapy
Study Arms  ICMJE
  • Experimental: Genotype 1b without cirrhosis
    12 weeks without Ribavirin
    Intervention: Drug: 12 weeks without Ribavirin
  • Experimental: Genotype 1b with cirrhosis
    12 weeks with Ribavirin
    Intervention: Drug: 12 weeks with Ribavirin
  • Experimental: Genotype 1a without cirrhosis
    12 weeks with Ribavirin
    Intervention: Drug: 12 weeks with Ribavirin
  • Experimental: Genotype 1a with cirrhosis
    24 weeks with Ribavirin
    Intervention: Drug: 24 weeks with Ribavirin
Publications * Deutsch L, Houri I, Ben-Ari Z, Shlomai A, Veitsman E, Cohen-Ezra O, Issachar A, Mor O, Gozlan Y, Bruck R, Menachem Y, Zelber-Sagi S, Katchman H, Shibolet O. Ombitasvir/paritaprevir/ritonavir & dasabuvir ± ribavirin following protease inhibitors failure - a prospective multi-centre trial. BMC Infect Dis. 2020 Apr 3;20(1):264. doi: 10.1186/s12879-020-4921-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02646111
Other Study ID Numbers  ICMJE TASMC-15-OS-503-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oren Shibolet, MD Tel-Aviv Sourasky Medical Center
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP