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A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Copegus
Copegus
Pegasys
Pegasys
boceprevir
boceprevir
mericitabine
mericitabine placebo
boceprevir placebo
boceprevir
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index <18 or >/=36
  • Hepatitis A, hepatitis B, or HIV infection
  • Herbal remedies </=1 month prior to the first dose of study drug

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment Arm A

Treatment Arm B

Treatment Arm C (Control)

Arm Description

24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.

24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.

4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.

Outcomes

Primary Outcome Measures

Sustained virological response 12 weeks after treatment (SVR-12)

Secondary Outcome Measures

Sustained virological response 4 weeks after treatment
Virologic response over time
Proportion of patients who develop treatment resistance
Safety (incidence of adverse events)
Pharmacokinetics: trough concentration of RO4995855
Pharmacokinetics: trough concentration of RO5012433
Pharmacokinetics: trough concentration of boceprevir

Full Information

First Posted
November 28, 2011
Last Updated
August 3, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01482403
Brief Title
A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
Official Title
A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm A
Arm Type
Experimental
Arm Description
24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Arm Title
Treatment Arm C (Control)
Arm Type
Active Comparator
Arm Description
4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
total daily dose of 1000 mg or 1200 mg for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
total daily dose of 1000 mg or 1200 mg for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
180 microgram subcutaneous once a week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
180 microgram subcutaneous once a week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
boceprevir
Intervention Description
800 mg three times a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
boceprevir
Intervention Description
800 mg three times a day for 48 weeks
Intervention Type
Drug
Intervention Name(s)
mericitabine
Intervention Description
1000 mg twice daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
mericitabine placebo
Intervention Description
mericitabine placebo
Intervention Type
Drug
Intervention Name(s)
boceprevir placebo
Intervention Description
boceprevir placebo
Intervention Type
Drug
Intervention Name(s)
boceprevir
Intervention Description
800 mg three times a day for 44 weeks
Primary Outcome Measure Information:
Title
Sustained virological response 12 weeks after treatment (SVR-12)
Time Frame
up to 60 weeks
Secondary Outcome Measure Information:
Title
Sustained virological response 4 weeks after treatment
Time Frame
up to 52 weeks
Title
Virologic response over time
Time Frame
60 weeks
Title
Proportion of patients who develop treatment resistance
Time Frame
60 weeks
Title
Safety (incidence of adverse events)
Time Frame
60 weeks
Title
Pharmacokinetics: trough concentration of RO4995855
Time Frame
Day 1 and Week 8
Title
Pharmacokinetics: trough concentration of RO5012433
Time Frame
Day 1 and Week 8
Title
Pharmacokinetics: trough concentration of boceprevir
Time Frame
Day 1 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, >/=18 years of age Chronic hepatitis C infection for at least 6 months duration Hepatitis C genotype 1a or 1b Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV Exclusion Criteria: Hepatitis C infection with a genotype other than genotype 1a or 1b Body mass index <18 or >/=36 Hepatitis A, hepatitis B, or HIV infection Herbal remedies </=1 month prior to the first dose of study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320-1706
Country
United States
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20121
Country
Italy
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26752189
Citation
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.
Results Reference
derived

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A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

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