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A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Primary Purpose

Hepatitis C

Status

Withdrawn

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Daclatasvir

Sofosbuvir

Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Daclatasvir + Sofosbuvir

Daclatasvir + Sofosbuvir + Ribavirin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02551861

First Posted

September 15, 2015

Last Updated

January 14, 2016

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02551861

Brief Title

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Official Title

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Withdrawn

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daclatasvir + Sofosbuvir

Arm Type

Active Comparator

Arm Description

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

Arm Title

Daclatasvir + Sofosbuvir + Ribavirin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Daclatasvir

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Post Treatment Follow up Week 12

Secondary Outcome Measure Information:

Title

Time Frame

Approximately 1.5 years

Title

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

Time Frame

Post treatment follow up Week 24

Title

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

Time Frame

Post Treatment Follow up Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Local Institution

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2S2

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1H2

Country

Canada

Facility Name

Local Institution

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2K5

Country

Canada

Facility Name

Local Institution

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

Local Institution

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Local Institution

City

Creteil Cedex

ZIP/Postal Code

94010

Country

France

Facility Name

Local Institution

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Local Institution

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Local Institution

City

Paris Cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Local Institution

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Local Institution

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

12. IPD Sharing Statement

Links:

URL

http://www.bms.com/studyconnect/Pages/home.aspx

Description

BMS clinical trial educational resource

Learn more about this trial

A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

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A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial