NCT02727933

Brief Summary

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,941

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

November 3, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

January 21, 2022

Status Verified

December 1, 2021

Enrollment Period

4.7 years

First QC Date

March 18, 2016

Last Update Submit

January 6, 2022

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities

    6 months to 5 years

Secondary Outcomes (5)

  • Incidence proportion of AEs leading to discontinuation of study therapy

    6 months to 5 years

  • Incidence rate of AEs leading to discontinuation of study therapy

    6 months to 5 years

  • Timing of laboratory abnormalities by toxicity grade

    6 months to 5 years

  • Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected

    4 Weeks to 24 Weeks

  • The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)

    24 Weeks to 36 Weeks

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
  • Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.

You may not qualify if:

  • Off-label use of Daklinza and Sunvepra
  • Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Seoul, South Korea

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 5, 2016

Study Start

November 3, 2015

Primary Completion

July 5, 2020

Study Completion

July 5, 2020

Last Updated

January 21, 2022

Record last verified: 2021-12

Locations

KR(1)