A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

NCT01292239 | Completed Phase 3 Results

• 2 other identifiers: CR017686TMC435HPC3003
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 28

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12)

  The table below shows the observed percentage of participants with a SVR12 defined as undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at EOT (Week 24 or 48) and at 12 weeks after the last dose of treatment (Week 36 or 60).

  EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)

Secondary Outcomes (9)

• The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24)

  EOT (up to Week 24 or 48) and 24 weeks after the after the last dose of treatment (up to Week 48 or 72)

• The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

  Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60, 72, EOT (up to Week 24 or 48), FU Week 4, 12, and 24

• The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)

  Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT (up to Week 24 or 48)

• The Number of Participants With Viral Breakthrough

  Up to EOT (up to Week 24 or 48)

• The Number of Participants Demonstrating Viral Relapse

  Up to Week 72

Study Arms (2)

TMC435 100 mg 12 Wks + PR 24/48

EXPERIMENTAL

Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 for participants who achieved HCV RNA \< 1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.

Drug: TMC435; Drug: Peginterferon alfa-2a (pegIFN alfa-2a); Drug: Ribavirin (RBV)

PBO 12 Wks + PR 48

EXPERIMENTAL

Participants received placebo (PBO) once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.

Drug: Placebo; Drug: Peginterferon alfa-2a (pegIFN alfa-2a); Drug: Ribavirin (RBV)

Interventions

Placebo DRUG

Placebo capsule taken by mouth once daily for 12 weeks

PBO 12 Wks + PR 48

TMC435 DRUG

100-mg capsule taken by mouth once daily for 12 weeks

TMC435 100 mg 12 Wks + PR 24/48

Peginterferon alfa-2a (pegIFN alfa-2a) DRUG

PegIFN alfa-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks for patients randomized to TMC435 and for up to 48 weeks for patients randomized to placebo.

Also known as: PEGASYS

PBO 12 Wks + PR 48; TMC435 100 mg 12 Wks + PR 24/48

Ribavirin (RBV) DRUG

RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is \> 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is \> 60 kg to \<=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is \<=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.

Also known as: COPEGUS

PBO 12 Wks + PR 48; TMC435 100 mg 12 Wks + PR 24/48

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have chronic genotype 1 HCV infection with HCV RNA level \>= 5.0 log10 IU/mL
• Patient has never received treatment for HCV
• Patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication

You may not qualify if:

• Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
• Diagnosed with hepatic cirrhosis or hepatic failure
• A medical condition which is a contraindication to pegIFN or ribavirin therapy
• History of, or any current medical condition which could impact the safety of the patient in the study

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (28)

Unknown Facility

Amagasaki, Japan

Location

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Chiba, Japan

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Chūō, Japan

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Hiroshima, Japan

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Ichikawa, Japan

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Ikeda, Japan

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Inashiki, Japan

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Iruma, Japan

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Kagoshima, Japan

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Kanazawa, Japan

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Kitakyushu, Japan

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Kumamoto, Japan

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Kurume, Japan

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Kyoto, Japan

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Matsumoto, Japan

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Musashino, Japan

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Nagoya, Japan

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Niigata, Japan

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Nishinomiya, Japan

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Ohmura, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Sakai, Japan

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Sapporo, Japan

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Sendai, Japan

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Tokyo, Japan

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Touon, Japan

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Yokohama, Japan

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MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Simeprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Director
• Organization: Janssen Pharmaceutical K.K., Japan

81 3 44115639

Study Officials

• Janssen Pharmaceutical K.K. Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 17, 2014
• Results First Posted: December 9, 2013

Record last verified: 2013-12

Locations

JP (28)