Clinical trial NCT02673489: A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection
Official title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.


Eligibility criteria: For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Genotype 3 HCV
* HCV RNA ≥10000 IU (International Unit)/mL
* Compensated Liver Cirrhosis
* BMI 18-40 kg/m2
* Previously treated for HCV or never treated for HCV

Exclusion Criteria:

* Infection with HCV other than Genotype 3. Mixed infection of any genotype
* Evidence of decompensated liver disease
* Previous exposure to NS5A inhibitors

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR12)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms
timeFrame: Week 12 (Follow-up period)
measure: Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24
timeFrame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)
measure: Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24
timeFrame: At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center Of USC
state: California
city: San Francisco
country: United States
facility: University Of California, San Francisco
state: California
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Chicago
country: United States
facility: Ruth Rothstein Core Center
state: Illinois
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: Methodist Transplant Physicians
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc
state: Virginia
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Regina
country: Canada
facility: Local Institution
state: Saskatchewan
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Poordad F, Shiffman ML, Ghesquiere W, Wong A, Huhn GD, Wong F, Ramji A, Shafran SD, McPhee F, Yang R, Noviello S, Linaberry M; ALLY-3C study team. Daclatasvir and sofosbuvir with ribavirin for 24 weeks in chronic hepatitis C genotype-3-infected patients with cirrhosis: a Phase III study (ALLY-3C). Antivir Ther. 2019;24(1):35-44. doi: 10.3851/IMP3278.