A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection

NCT01846832 | Completed Phase 3 DMC

• 3 other identifiers: CR100981TMC435HPC30142012-004905-29
• Study Type: interventional
• Target: 232
• Locations: 7 countries
• Sites: 20

Brief Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

Conditions

Hepatitis C, Chronic; Infection

Keywords

Hepatitis C, Chronic; Infection; Triple therapy; TMC435; simeprevir; Pegylated interferon alfa-2a (PegIFNα-2a); ribavirin (RBV); PEGASYS; COPEGUS

Outcome Measures

Primary Outcomes (1)

• The proportion (percentage) of participants infected wtih genotype 1 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)

  Participants are considered to have reached SVR12 if at the actual end of treatment hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL undetectable, AND at the time point of SVR12 (i.e., 12 weeks after the planned end of treatment \[EOT\]), HCV RNA levels \< 25 IU/mL undetectable.

  Week 24

Secondary Outcomes (17)

• The proportion (percentage) of participants infected wtih genotype 4 HCV with a sustained virologic response 12 weeks after planned end of treatment (SVR12)

  Week 24

• The proportion (percentage) of participants who achieve rapid virologic response (RVR)

  Week 4

• The proportion (percentage) of participants who achieve virologic response at Week 2 (W2VR)

  Week 2

• The proportion (percentage) of participants with sustained virologic response 24 weeks after planned end of treatment (SVR24)

  Week 48

• The proportion (percentage) of participants with sustained virologic response 12 weeks after planned end of treatment (SVR12)

  Week 24

Study Arms (1)

TMC435 + PegIFNα-2a + RBV

EXPERIMENTAL

TMC435 will be administered as triple therapy with pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV).

Drug: TMC435; Drug: Pegylated interferon alfa-2a (PegIFNα-2a); Drug: Ribavirin (RBV)

Interventions

TMC435 DRUG

150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.

TMC435 + PegIFNα-2a + RBV

Pegylated interferon alfa-2a (PegIFNα-2a) DRUG

180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.

Also known as: Pegasys

TMC435 + PegIFNα-2a + RBV

Ribavirin (RBV) DRUG

1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is \< 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is \> or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).

Also known as: Copegus

TMC435 + PegIFNα-2a + RBV

Eligibility Criteria

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

You may qualify if:

• treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection
• liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
• liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)

You may not qualify if:

• Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV co-infection will be excluded from the study

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (20)

Unknown Facility

Linz, Austria

Location

Unknown Facility

Vienna, Austria

Location

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Brussels, Belgium

Location

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Edegem, Belgium

Location

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Clichy, France

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Limoges, France

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Orléans, France

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Saint-Laurent-du-Var, France

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Berlin, Germany

Location

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Düsseldorf, Germany

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Frankfurt, Germany

Location

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Hamburg, Germany

Location

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Würzburg, Germany

Location

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Riyadh, Saudi Arabia

Location

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Barcelona, Spain

Location

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Madrid, Spain

Location

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Valencia, Spain

Location

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Valme, Spain

Location

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Glasgow, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (2)

• Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Sanai F, Bicer C, Lenz O, Van Dooren G, Nalpas C, Lonjon-Domanec I, Schlag M, Buti M. Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection and Mild-To-Moderate Fibrosis Displaying Early On-Treatment Virologic Response. PLoS One. 2017 Jan 5;12(1):e0168713. doi: 10.1371/journal.pone.0168713. eCollection 2017.

  PMID: 28056030 DERIVED

• Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.

  PMID: 27428331 DERIVED

Related Links

• A Phase 3, Open-Label Study to Evaluate the Safety and Efficacy of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects with Chronic Genotype 1 or Genotype 4 HCV Infection

MeSH Terms

Conditions

Hepatitis C, Chronic; Infections

Interventions

Simeprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; 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

Study Officials

• JJanssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

AU (2); DE (5); FR (4); ES (4); GB (2); SA (1); BE (2)