A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

Browse trials for

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

Hepatitis A

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

This study's enrollment of 80 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)

  Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).

  Drug: Ribavirin · Drug: Mericitabine · Drug: Peginterferon Alfa-2a · Drug: Telaprevir

• Experimental
  TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)

  Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

  Drug: Ribavirin · Drug: Mericitabine · Drug: Peginterferon Alfa-2a · Drug: Telaprevir

• Experimental
  TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)

  Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

  Drug: Ribavirin · Drug: Mericitabine · Drug: Peginterferon Alfa-2a · Drug: Placebo · Drug: Telaprevir

• Active comparator
  TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)

  Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).

  Drug: Ribavirin · Drug: Peginterferon Alfa-2a · Drug: Placebo · Drug: Telaprevir

Interventions

• DrugRibavirin

  Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.

  Also known as: Copegus

• DrugMericitabine

  Participants will receive mericitabine 1000 mg orally twice daily.

• DrugPeginterferon Alfa-2a

  Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.

  Also known as: Pegasys

• DrugPlacebo

  Participants will receive placebo matching to mericitabine orally twice daily.

• DrugTelaprevir

  Participants will receive telaprevir 750 mg orally three times daily.

Primary outcomes

1. Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test

   Time frame: 12 weeks after end of treatment (up to Week 60)

Secondary outcomes

1. Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test

   Time frame: 4 weeks after end of treatment (up to Week 52)

2. Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test

   Time frame: 24 weeks after end of treatment (up to Week 72)

3. Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test

   Time frame: Weeks 2, 4, 12, 24, and 48

4. Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology

   Time frame: Baseline up to Week 60

5. Change From Baseline in HCV Ribonucleic Acid (RNA) Levels

   Time frame: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72

6. Percentage of Participants With Adverse Event

   Time frame: Baseline up to Week 72

7. Trough Concentration of RO4995855 (Parent Drug of Mericitabine)

   Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8

8. Trough Concentration of Metabolite of RO4995855 (RO5012433)

   Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8

9. Trough Concentration of Telaprevir

   Time frame: Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8

Publications

• Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016. PubMed 26752189 ↗