NCT02646111

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

December 28, 2015

Last Update Submit

January 4, 2016

Conditions

Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • "SVR" (sustained virologic response) rates

    Sustained virologic response

    12 weeks after end of treatment

Secondary Outcomes (2)

  • "SF" (short-form)-36 health survey

    Day 1, weeks 4, 12, 24, 36.

  • WPAI Hep C v2.0 questionnaire

    Day 1, weeks 4, 12, 24, 36.

Study Arms (4)

Genotype 1b without cirrhosis

EXPERIMENTAL

12 weeks without Ribavirin

Drug: 12 weeks without Ribavirin

Genotype 1b with cirrhosis

EXPERIMENTAL

12 weeks with Ribavirin

Drug: 12 weeks with Ribavirin

Genotype 1a without cirrhosis

EXPERIMENTAL

12 weeks with Ribavirin

Drug: 12 weeks with Ribavirin

Genotype 1a with cirrhosis

EXPERIMENTAL

24 weeks with Ribavirin

Drug: 24 weeks with Ribavirin

Interventions

12 weeks without RibavirinDRUG

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

Also known as: Triple therapy
Genotype 1b without cirrhosis
12 weeks with RibavirinDRUG

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.

Also known as: Triple therapy
Genotype 1a without cirrhosisGenotype 1b with cirrhosis
24 weeks with RibavirinDRUG

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.

Also known as: Triple therapy
Genotype 1a with cirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32245397DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Oren Shibolet, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oren Shibolet, MD

CONTACT

97236973984orensh@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and Development manager

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 5, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

January 5, 2016

Record last verified: 2016-01