Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00990938
First received: October 6, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard weight based ribavirin (investigational treatment arm) or placebo in combination with ribavirin (RBV). Each cohort of 15 patients will be randomized 4:1 to receive the investigational treatment arm (12 patients) or placebo and RBV arm (3 patients).


Condition Intervention Phase
Hepatitis C, Treatment Naïve, Genotype 1 Patients
Drug: IMO-2125
Drug: Saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-center, Randomized, Double-Blind, Placebo-controlled, Dose-escalation Safety Assessment Study of Combination Treatment With IMO-2125 and Ribavirin in Naïve Hepatitis C-infected, Genotype 1 Patients

Resource links provided by NLM:


Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of 3 different dosages of IMO-2125 in combination with standard ribavirin compared to placebo and ribavirin. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess rapid viral response (RVR) rate, defined as undetectable HCV-RNA at week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Assess the effects of 3 different dosages of IMO-2125 in combination with standard ribavirin on viral load [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Characterize the pharmacodynamics in combination with ribavirin in HCV-infected patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Describe the viral kinetics per individual patient [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
If randomized to placebo the patient will receive a subcutaneous injection once per week for 4 weeks
Drug: Saline
Subcutaneous injection once per week for four weeks
Experimental: IMO-2125
If randomized to receive the experimental treatment, IMO-2125, the patient will receive a subcutaneous injection once per week for 4 weeks
Drug: IMO-2125
IMO 2125 is a synthetic DNA-based agonist of Toll-like receptor 9, which is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system.

Detailed Description:

This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study with 3 dose levels of IMO-2125 in combination with standard ribavirin or placebo plus ribavirin. Each cohort will be randomized 4:1 to receive the investigational treatment arm or placebo and ribavirin. Three varying dose levels of IMO-2125 will be included. In both arms, ribavirin will be dosed based on patient weight.

Approximately 50 patients will be enrolled in France and Russia. Patients will provide informed consent prior to any screening procedures being performed. Screening will occur within 21 days prior to randomization. Enrolled patients who qualify and proceed successfully through the screening period will be randomized to receive 4 weeks of either the investigational treatment arm (IMO-2125 and ribavirin) or placebo and ribavirin, with a 4 week follow-up period.

Patients who are randomized to the investigational treatment arm will receive one of 3 dose levels of IMO 2125 SC once weekly; each patient will receive the same dose throughout the 4 weeks of treatment. In addition to IMO-2125 treatment they will also receive daily ribavirin, which will be given based on the patients weight and will be taken twice daily for a total of 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented genotype 1
  • HCV-positive with documented detectable plasma viral concentration > 10,000 IU/mL

Exclusion Criteria:

  • Positive test for HIV or HbsAg
  • Inadequate bone marrow, liver, and renal function
  • Treatment with any IFN-based or other experimental or antiviral therapies - prior or current
  • Other significant medical disease
  • Concurrent or planned treatment during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990938

Locations
France
Rennes, France, 35000
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Idera Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00990938     History of Changes
Other Study ID Numbers: IMO-2125-201
Study First Received: October 6, 2009
Last Updated: May 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014