Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Hepatitis C Clinical Trial

— FOURward  

Official title:

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis C (FOURward Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175966
• Other study ID #: AI443-131
• Status: Completed
• Phase: Phase 2
• Start date: July 28, 2014
• Est. completion date: December 17, 2015

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Description:

Allocation:

Initial Therapy: Randomized Controlled Trial: Participants are assigned to intervention groups by chance

Rescue Therapy: Nonrandomized Trial: Participants are expressly assigned to intervention groups through a non-random method such as physician choice

Number of Arms:

Initial Therapy: 2 Groups

Rescue Therapy: 2 Groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 17, 2015
• Est. primary completion date: January 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Inclusion Criteria:

• Males and Females =18 years of age, inclusive

• Chronic HCV infection Genotype 1 only

• Non-cirrhotic

• Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNa, pegIFNa), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria:

• HCV Genotype other than Genotype 1

• Documented or suspected hepatocellular carcinoma

• Evidence of decompensated liver disease

• Contraindication(s) to Peg/RBV therapy

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• DCV/ASV/BMS-791325

• Ribavirin

• Sofosbuvir

• Peginterferon a-2a

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Northwestern University Feinberg School Of Medicine	Chicago	Illinois
United States	Indiana University Health - University Hospital	Indianapolis	Indiana
United States	Indiana University Med Center	Indianapolis	Indiana
United States	Johns Hopkins University	Lutherville	Maryland
United States	Inland Empire Liver Foundation	Rialto	California
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 (SVR12)	SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.	12 Weeks after treatment discontinuation (Follow-up Week 12)
Primary	Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment	SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.	From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Primary	Number of Participants With Selected Grade 3/4 Laboratory Abnormalities	Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.	From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)
Secondary	Percentage of Participants With End of Treatment Response (EOTR)	EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.	End of the treatment
Secondary	Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND	Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).	Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)
Secondary	Percentage of Participants Who Achieved HCV RNA < LLOQ TND	Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).	Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24
Secondary	Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b	Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b	Post-treatment Week 12
Secondary	Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)	Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.	Post-treatment Week 12

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry form