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Completed

NCT Number: NCT01011166

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

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Key information

Conditions

Chronic Hepatitis C Infection Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic 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

  • Has documented chronic HCV GT1 infection
  • Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy

Exclusion criteria

  • Has received previous antiviral treatment for HCV infection
  • Has cirrhosis or decompensated liver disease
  • Is pregnant or breastfeeding
  • Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV)
  • Has clinically significant concomitant disease

Treatment and study plan

IDX184

Drug

IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.

Placebo

Drug

Placebo white opaque capsules taken by mouth from Day 1 to Day 14.

Peginterferon alfa-2a (Peg-IFN)

Biological

Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.

Other names: Pegasys

ribavirin (RBV)

Drug

RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.

Primary outcomes

  1. Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15

    Time frame: Baseline and Day 15

  2. Percentage of participants experiencing adverse events (AEs)

    Time frame: Up to 28 days

  3. Percentage of participants experiencing serious adverse events (SAEs)

    Time frame: Up to 28 days

  4. Percentage of participants experiencing dose-limiting toxicities (DLTs)

    Time frame: Up to 28 days

  5. Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Time frame: Up to 28 days

Secondary outcomes

  1. Change in HCV RNA level from Baseline to Day 28

    Time frame: Baseline and Day 28

  2. Percentage of participants with undetectable HCV RNA at Day 15

    Time frame: Day 15

  3. Percentage of participants with undetectable HCV RNA at Day 28

    Time frame: Day 28

  4. Percentage of participants experiencing virologic breakthrough while on study therapy

    Time frame: Up to 28 days

  5. Change in alanine aminotransferase (ALT) level from Baseline to Day 15

    Time frame: Baseline and Day 15

  6. Change in ALT level from Baseline to Day 28

    Time frame: Baseline and Day 28

  7. Maximum concentration (Cmax)

    Time frame: Up to 28 days

  8. Time to maximum concentration (Tmax)

    Time frame: Up to 28 days

  9. Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)

    Time frame: Up to 28 days

  10. AUC from time zero to infinity (AUC0-~)

    Time frame: Up to 28 days

  11. Trough concentration (Ctrough)

    Time frame: Up to 28 days

  12. Observed terminal half-life (Thalf)

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 11, 2009
Registry last updated
Apr 23, 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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