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Completed

NCT Number: NCT01371604

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females with documented genotype 1, chronic hepatitis C infection.
  • Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
  • Has not received prior antiviral treatment for HCV.
  • Written informed consent by participant.

Exclusion criteria

  • Pregnant or breastfeeding.
  • Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).

Treatment and study plan

IDX184

Drug

IDX184 50 mg tablet administered orally

Peginterferon alfa-2a (Peg-IFN)

Biological

Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly

Other names: Pegasys

ribavirin (RBV)

Drug

Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.

Placebo

Drug

Matching placebo to IDX184 50 mg tablet administered orally

Primary outcomes

  1. Percentage of participants who experience a serious adverse event

    Time frame: Up to Week 16 and end of treatment (Weeks 24 or 48)

  2. Percentage of participants who experience an adverse event

    Time frame: 16 weeks

  3. Percentage of participants who experience a grade 1-4 laboratory abnormality

    Time frame: 16 weeks

  4. Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12

    Time frame: Week 12

Secondary outcomes

  1. Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4

    Time frame: Week 4

  2. Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment

    Time frame: Weeks 24 or 48

  3. Percentage of participants who achieve sustained virologic response (SVR)

    Time frame: 24 weeks after the last dose (Weeks 48 or 72)

  4. Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4

    Time frame: Week 4

  5. Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment

    Time frame: Weeks 24 or 48

  6. Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)

    Time frame: Weeks 48 or 72

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jun 13, 2011
Registry last updated
Feb 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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