Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01011166
Other study ID # 2355-004
Secondary ID IDX-08C-004
Status Completed
Phase Phase 2
First received October 2, 2009
Last updated April 22, 2015
Start date November 2009
Est. completion date July 2010

Study information

Verified date April 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
IDX184
IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
Placebo
Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
Biological:
Peginterferon alfa-2a (Peg-IFN)
Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
Drug:
Ribavirin (RBV)
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bólyai J, Mayers D. IDX184 in combination with pegylated interferon-a2a and rib — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15 Baseline and Day 15 No
Primary Percentage of participants experiencing adverse events (AEs) Up to 28 days Yes
Primary Percentage of participants experiencing serious adverse events (SAEs) Up to 28 days Yes
Primary Percentage of participants experiencing dose-limiting toxicities (DLTs) Up to 28 days Yes
Primary Percentage of participants experiencing Grade 1-4 laboratory abnormalities Up to 28 days Yes
Secondary Change in HCV RNA level from Baseline to Day 28 Baseline and Day 28 No
Secondary Percentage of participants with undetectable HCV RNA at Day 15 Day 15 No
Secondary Percentage of participants with undetectable HCV RNA at Day 28 Day 28 No
Secondary Percentage of participants experiencing virologic breakthrough while on study therapy Up to 28 days No
Secondary Change in alanine aminotransferase (ALT) level from Baseline to Day 15 Baseline and Day 15 No
Secondary Change in ALT level from Baseline to Day 28 Baseline and Day 28 No
Secondary Maximum concentration (Cmax) Up to 28 days No
Secondary Time to maximum concentration (Tmax) Up to 28 days No
Secondary Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t) Up to 28 days No
Secondary AUC from time zero to infinity (AUC0-~) Up to 28 days No
Secondary Trough concentration (Ctrough) Up to 28 days No
Secondary Observed terminal half-life (Thalf) Up to 28 days No
See also
  Status Clinical Trial Phase
Completed NCT02216422 - A Study to Evaluate Chronic Hepatitis C Infection in Cirrhotic Adults With Genotype 1b Infection Phase 3
Completed NCT02219503 - A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis Phase 3
Completed NCT01700179 - Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants Phase 1
Completed NCT02486406 - A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects Phase 2/Phase 3
Completed NCT01704755 - A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis Phase 3
Completed NCT01225380 - A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C Phase 2
Completed NCT01221298 - A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) Phase 2
Completed NCT01715415 - A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults Phase 3
Completed NCT01716585 - A Study to Evaluate Chronic Hepatitis C Infection Phase 3
Completed NCT02065999 - Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients
Completed NCT01453075 - Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I) Phase 1
Completed NCT00557583 - Evaluation of Safety and Pharmacokinetics of Single Doses of VBY-376 in Healthy Adults Phase 1
Terminated NCT01586325 - A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients Phase 1
Recruiting NCT02578693 - Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)
Recruiting NCT02583685 - Switching Regimen in Treating Cirrhotic HCV GT1b Subjects Phase 2
Completed NCT02576314 - Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients Phase 3
Not yet recruiting NCT01835938 - Clinical Investigation of Erlotinib as an HCV Entry Inhibitor Phase 1/Phase 2
Completed NCT01055821 - Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients Phase 2
Completed NCT01854697 - A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before Phase 3
Completed NCT01833533 - A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection Phase 3