NCT02551861

Brief Summary

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

Geographic Reach
2 countries

12 active sites

Status
withdrawn

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

September 15, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

September 15, 2015

Last Update Submit

January 14, 2016

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)

    SVR12 defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy

    Post Treatment Follow up Week 12

Secondary Outcomes (3)

  • Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing

    Approximately 1.5 years

  • Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm

    Post treatment follow up Week 24

  • Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm

    Post Treatment Follow up Week 12

Study Arms (2)

Daclatasvir + Sofosbuvir

ACTIVE COMPARATOR

Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks

Drug: DaclatasvirDrug: Sofosbuvir

Daclatasvir + Sofosbuvir + Ribavirin

ACTIVE COMPARATOR

Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks

Drug: DaclatasvirDrug: SofosbuvirDrug: Ribavirin

Interventions

DaclatasvirDRUG
Daclatasvir + SofosbuvirDaclatasvir + Sofosbuvir + Ribavirin
SofosbuvirDRUG
Daclatasvir + SofosbuvirDaclatasvir + Sofosbuvir + Ribavirin
RibavirinDRUG
Daclatasvir + Sofosbuvir + Ribavirin

Eligibility Criteria

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

You may qualify if:

  • Genotype 3
  • HCV RNA \< 2000000 IU/mL
  • Never taken HCV medication
  • Absence of advanced fibrosis or cirrhosis
  • Body mass index (BMI) 18-40 kg/m\^2

You may not qualify if:

  • Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
  • Previously taken HCV medication
  • Liver Cirrhosis
  • Evidence of decompensated liver disease
  • HIV/ hepatitis B virus (HBV) coinfection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Local Institution

Calgary, Alberta, T2N 4Z6, Canada

Location

Local Institution

Edmonton, Alberta, T6G 2S2, Canada

Location

Local Institution

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Local Institution

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Local Institution

Victoria, British Columbia, V8V 3P9, Canada

Location

Local Institution

Toronto, Ontario, M5G 2C4, Canada

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Limoges, 87042, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Paris, 75679, France

Location

Local Institution

Pessac, 33604, France

Location

Local Institution

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirSofosbuvirRibavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

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

September 15, 2015

First Posted

September 16, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

CA(6)FR(6)