NCT02094443

Brief Summary

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Geographic Reach
2 countries

16 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 13, 2016

Completed
Last Updated

October 13, 2016

Status Verified

August 1, 2016

Enrollment Period

1.1 years

First QC Date

March 18, 2014

Results QC Date

June 30, 2016

Last Update Submit

August 19, 2016

Conditions

Hepatitis CLiver Disease

Keywords

Chronic hepatitis C genotype 2Chronic hepatitis C genotype 3Cyclophilin inhibitorInterferon intolerant

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12

    The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.

    Baseline, Week 12

  • Change From Baseline in Alanine Aminotransferase (ALT) at Week 12

    ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.

    Baseline, Week 12

Secondary Outcomes (5)

  • Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment

    Up to 24 weeks posttreatment

  • Percentage of Participants With Extended Rapid Virologic Response

    2 weeks

  • Percentage of Participants With Rapid Virologic Response (RVR)

    4 weeks

  • Percentage of Participants With End of Treatment Response (ETR)

    Up to 24 weeks

  • Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End

    Up to 24 weeks

Study Arms (2)

Alisporivir 300 mg BID

EXPERIMENTAL

Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Drug: AlisporivirDrug: Ribavirin

Alisporivir 400 mg BID

EXPERIMENTAL

ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication

Drug: AlisporivirDrug: Ribavirin

Interventions

AlisporivirDRUG

ALV 100 and 200 mg soft gel capsules administered orally

Also known as: DEB025
Alisporivir 300 mg BIDAlisporivir 400 mg BID
RibavirinDRUG

RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Also known as: Copegus®
Alisporivir 300 mg BIDAlisporivir 400 mg BID

Eligibility Criteria

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

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed
  • Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
  • Males or females aged ≥18 years
  • Diagnosed Chronic hepatitis C virus infection

You may not qualify if:

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Hepatitis B surface antigen (HBsAg) positive
  • Human immunodeficiency virus (HIV) positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Novartis Investigative Site

Bakersfield, California, 93301, United States

Location

Novartis Investigative Site

Lancaster, California, 93534, United States

Location

Novartis Investigative Site

San Diego, California, 92114, United States

Location

Novartis Investigative Site

San Diego, California, 92128, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63110, United States

Location

Novartis Investigative Site

Arlington, Texas, 76012, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

San Antonio, Texas, 78215, United States

Location

Novartis Investigative Site

Newport News, Virginia, 23602, United States

Location

Novartis Investigative Site

Seattle, Washington, 98101, United States

Location

Novartis Investigative Site

Seattle, Washington, 98104, United States

Location

Novartis Investigative Site

Clichy, 92110, France

Location

Novartis Investigative Site

Créteil, 94010, France

Location

Novartis Investigative Site

Lyon, 69317, France

Location

Novartis Investigative Site

Nice, 06202, France

Location

Novartis Investigative Site

Paris, 75014, France

Location

MeSH Terms

Conditions

Hepatitis CLiver Diseases

Interventions

alisporivirRibavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Vice President Clinical Research & Development
Organization
Debiopharm International S.A.
info-international@debiopharm.com
4121 321 01 11

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 13, 2016

Results First Posted

October 13, 2016

Record last verified: 2016-08

Locations

FR(5)US(11)