A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Keywords

• hepatitis C

Hepatitis A

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

This study's enrollment of 45 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Vaniprevir 300 mg b.i.d. + peg-IFN + RBV

  Participants received vaniprevir 300 mg twice daily (b.i.d.) in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

  Drug: Vaniprevir 300 mg b.i.d. · Drug: Pegylated interferon · Drug: Ribavirin

• Experimental
  Vaniprevir 600 mg b.i.d. + peg-IFN + RBV

  Participants received vaniprevir 600 mg b.i.d. in combination peg-IFN 180 mcg weekly and ribavirin (1000 or 1200 mg) administered as a divided dose twice daily.

  Drug: Vaniprevir 600 mg b.i.d. · Drug: Pegylated interferon · Drug: Ribavirin

Interventions

• DrugVaniprevir 600 mg b.i.d.

  Oral capsules containing 150 mg vaniprevir, four in the morning and four in the evening, for 48 weeks

• DrugVaniprevir 300 mg b.i.d.

  Oral capsules containing 150 mg vaniprevir, two in the morning and two in the evening, for 48 weeks

• DrugPegylated interferon

  Prefilled syringe containing 180 µg/0.5 mL peg-IFN, for weekly subcutaneous injection, for 48 weeks

  Also known as: PEGASYS™

• DrugRibavirin

  Oral tablets containing 200 mg RBV, 5 or 6 tablets, dosage based on the participant's weight (\<75 kg or ≥75 kg, respectively), for 48 weeks

  Also known as: COPEGUS™

Primary outcomes

1. Number of Participants Who Experienced an Adverse Event

   An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

   Time frame: up to 72 weeks

2. Number of Participants Who Experienced a Serious Adverse Event

   Serious adverse event is defined as any adverse drug or biologic or device experience occurring at any dose resulting in death, was life-threatening, was persistent or caused significant disability/incapacity, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly or birth defect, was a cancer, or was an overdose.

   Time frame: up to 72 weeks

3. Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

   An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

   Time frame: 48 weeks

4. Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)

   SVR24 is defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) 24 weeks after the end of vaniprevir study therapy. HCV RNA plasma levels were assessed using the Roche COBAS Taqman assay (or equivalent) with the limit of quantification (LoQ) of at least 25 IU/mL and the limit of detection (LoD) of at least 10 IU/mL.

   Time frame: 72 weeks

Baseline characteristics

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf