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Completed

NCT Number: NCT02175966

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inland Empire Liver Foundation, Rialto, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, IFNα, pegIFNα), 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

Treatment and study plan

DCV/ASV/BMS-791325

Drug

Ribavirin

Drug

Sofosbuvir

Drug

Other names: Sovaldi®

Peginterferon α-2a

Drug

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 (SVR12)

    Time frame: 12 Weeks after treatment discontinuation (Follow-up Week 12)

    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.

  2. Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment

    Time frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

    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.

  3. Number of Participants With Selected Grade 3/4 Laboratory Abnormalities

    Time frame: From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)

    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.

Secondary outcomes

  1. Percentage of Participants With End of Treatment Response (EOTR)

    Time frame: End of the treatment

    EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.

  2. Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND

    Time frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)

    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).

  3. Percentage of Participants Who Achieved HCV RNA < LLOQ TND

    Time frame: Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24

    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).

  4. Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b

    Time frame: Post-treatment Week 12

    Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b

  5. Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)

    Time frame: Post-treatment Week 12

    Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: FOURward

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2014
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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