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Hepatitis CPhase 2NCT01482390

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

A Phase 2 study testing Ribavirin, Mericitabine and Peginterferon Alfa-2a in people with Hepatitis C, run by Hoffmann-La Roche at 39 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Ribavirin, Mericitabine and Peginterferon Alfa-2a
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
39 sitesin 7 countries
Study dates
30 Nov 2011to 31 Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Who cannot join

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index < 18 or >= 36 kilograms per square meters (kg/m^2)
  • Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
  • Herbal remedies <=1 month prior to the first dose of study drug

Trial locations and contacts

39 sites in 7 countries.

39 sites in 7 countries

United States15 sites

  • Birmingham Gastro Associates, P.C.

    Birmingham, Alabama, 35209

  • Uni of Cincinnati College of Medicine; Div. of Digestive Diseases

    Cincinnati, Ohio, 45267-0595

  • Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons

    Dallas, Texas, 75246

  • Metrowest Medical Center

    Framingham, Massachusetts, 01702

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • John Hopkins Hospital

    Lutherville, Maryland, 21093

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Yale University

    New Haven, Connecticut, 06510

  • Weill Cornell Medical College

    New York, New York, 10021

  • McGuire; Veteran Affairs Med Ctr

    Richmond, Virginia, 23249

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • UCSD Antiviral Research Center

    San Diego, California, 92103

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

    St Louis, Missouri, 63104

  • Carolina'S Center For Liver Disease

    Statesville, North Carolina, 28677

Other trials in United States

Canada7 sites

  • McGill University, Montreal Chest Institute; Viral and other Infectious

    Montreal, Quebec, H2X2P4

  • University Health Network - Toronto Western Hospital; Hepatology

    Toronto, Ontario, M5G 1L7

  • Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology

    Vancouver, British Columbia, V5Z 1M9

  • GI Research Institute; Gastroenterology & Hepatology

    Vancouver, British Columbia, V6Z 2K5

  • Percuro Clinical Research Ltd.

    Victoria, British Columbia, V8V 3P9

  • Winnipeg Regional Health Authority; Section of Hepatology

    Winnipeg, Manitoba, R3A 1R9

  • Toronto Digest. Disease Asso.

    Woodbridge, Ontario, L4L 4Y7

Other trials in Canada

Spain4 sites

  • Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

    Barcelona, 08035

  • Hospital Clinic I Provincial; Servicio de Digestivo

    Barcelona, 08036

  • Hospital Carlos III; Laboratorio de Biologia Molecular

    Madrid, 28029

  • Hospital Universitario de Canarias; Servicio de Digestivo

    San Cristóbal de La Laguna, Tenerife, 38320

Other trials in Spain

United Kingdom4 sites

  • Royal Bournemouth Hospital, Gastroenterology

    Dorset, BH7 7DW

  • King'S College Hospital; Institute of Liver Studies

    London, SE5 9RS

  • St George's Hospital

    London, SW17 0QT

  • Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility

    London, W2 1NY

Other trials in United Kingdom

France3 sites

  • Hopital Claude Huriez;Gastro Enterologie

    Lille, 59037

  • Fondation Hopital Saint Joseph; Gastro-Enterologie

    Marseille, 13285

  • Hopital Purpan;Gastro Enterologie Hepatologie

    Toulouse, 31059

Other trials in France

Germany3 sites

  • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

    Frankfurt am Main, 60590

  • Uniklinik Freiburg; Abteilung Innere Medizin II

    Freiburg im Breisgau, 79106

  • Universitäts Klinikum; Schleswig-Holstein Kiel

    Kiel, 24105

Other trials in Germany

Italy3 sites

  • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

    Bologna, Emilia-Romagna, 40138

  • ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive

    Milan, Lombardy, 20162

  • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia

    Pisa, Tuscany, 56124

Other trials in Italy

About this study

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 Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

Conditions
Hepatitis C
Being tested
Ribavirin, Mericitabine, Peginterferon Alfa-2a, Placebo, Telaprevir
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibavirinDrug

    Also called Copegus

    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.

  • MericitabineDrug

    Participants will receive mericitabine 1000 mg orally twice daily.

  • Peginterferon Alfa-2aDrug

    Also called Pegasys

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

  • PlaceboDrug

    Participants will receive placebo matching to mericitabine orally twice daily.

  • TelaprevirDrug

    Participants will receive telaprevir 750 mg orally three times daily.

Study groups in NCT01482390
Study groupRoleWhat they receive
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)ExperimentalTwelve 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).
Receives: Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Telaprevir
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)ExperimentalTwelve 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).
Receives: Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Telaprevir
TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)ExperimentalTwelve 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).
Receives: Drug: Ribavirin; Drug: Mericitabine; Drug: Peginterferon Alfa-2a; Drug: Placebo; Drug: Telaprevir
TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)Active comparatorTwelve 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).
Receives: Drug: Ribavirin; Drug: Peginterferon Alfa-2a; Drug: Placebo; Drug: Telaprevir

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (9)

  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

    Measured: 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

    Measured: 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

    Measured: Weeks 2, 4, 12, 24, and 48

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

    Measured: Baseline up to Week 60

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

    Measured: 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

    Measured: Baseline up to Week 72

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

    Measured: 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)

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2011 (estimated)
  2. Study start30 Nov 2011
  3. Primary completion31 Jan 2014
  4. Study completion31 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01482390
Sponsor's protocol ID
NV27779
Other IDs
2011-002715-28
Status last verified
Apr 2017
First submitted
28 Nov 2011
Last updated
24 Apr 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ribavirin, Mericitabine and Peginterferon Alfa-2a in people with Hepatitis C, run by Hoffmann-La Roche at 39 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Canada, Spain, United Kingdom, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01482390, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.

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