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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

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.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: 12 weeks without Ribavirin Drug: 12 weeks with Ribavirin Drug: 24 weeks with Ribavirin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Genotype 1b without cirrhosis
12 weeks without Ribavirin
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

Experimental: Genotype 1b with cirrhosis
12 weeks with Ribavirin
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

Experimental: Genotype 1a without cirrhosis
12 weeks with Ribavirin
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

Experimental: Genotype 1a with cirrhosis
24 weeks with Ribavirin
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




Primary Outcome Measures :
  1. "SVR" (sustained virologic response) rates [ Time Frame: 12 weeks after end of treatment ]
    Sustained virologic response


Secondary Outcome Measures :
  1. "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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02646111


Contacts
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Contact: Oren Shibolet, MD 97236973984 orensh@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Oren Shibolet, MD Tel-Aviv Sourasky Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: michal roll, Research and Development manager, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02646111    
Other Study ID Numbers: TASMC-15-OS-503-CTIL
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
"Hepatitis C Virus"
"Triple Therapy"
"PI Failure"
"Genotype 1"
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents