Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis 3,380

Keywords

• hepatitis C virus

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 152 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Study arms

• Experimental
  BMS-790052 + PegIFNα-2a + Ribavirin

  * BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response * Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response

  Drug: BMS-790052 (NS5A Replication Complex Inhibitor) · Drug: Pegylated-interferon alfa 2a · Drug: Ribavirin

• Placebo comparator
  Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

  * Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks * PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks * Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

  Drug: Placebo matching BMS-790052 · Drug: Pegylated-interferon alfa 2a · Drug: Ribavirin

Interventions

• DrugBMS-790052 (NS5A Replication Complex Inhibitor)
• DrugPlacebo matching BMS-790052
• DrugPegylated-interferon alfa 2a

  Also known as: Pegasys

• DrugRibavirin

  Also known as: Copegus

Primary outcomes

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

   Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.

   Time frame: Week 12 (Follow-up period)

Secondary outcomes

1. Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)

   Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.

   Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48

2. Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels

   Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.

   Time frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48

3. Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene

   Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.

   Time frame: Post Treatment Weeks 12, 24

4. Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died

   AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.

   Time frame: From Day 1 (start of study treatment) up to Follow-up Week 4

Baseline characteristics

Publications

• Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print. PubMed 26313445 ↗

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