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Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

IMO-2125

Saline placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HCV-positive
Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin

Exclusion Criteria:

Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg)
Inadequate bone marrow, liver, and renal function
Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days
Other significant medical diseases
Known alcohol or drug abuse within the past 12 months

Sites / Locations

University of Colorado Hospital
Gastoenterstinal Specialist of Georgia, PA
Henry Ford Med Ctr- Columbus
Duke University Medical Center
The Liver Institute
Alamo Medical Research
Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

IMO-2125 0.04 mg/kg q week

IMO-2125 0.08 mg/kg q week

IMO-2125 0.16 mg/kg q week

IMO-2125 0.32 mg/kg q week

IMO-2125 0.48 mg/kg q week

Placebo

IMO-2125 0.16 mg/kg twice a week

Arm Description

IMO-2125 given weekly at 0.04 mg/kg

IMO-2125 given weekly at 0.08 mg/kg

IMO-2125 given weekly at 0.16 mg/kg

IMO-2125 given weekly at 0.32 mg/kg

IMO-2125 given weekly at 0.48 mg/kg

Weekly saline placebo

IMO-2125 given twice a week at 0.16 mg/kg

Outcomes

Primary Outcome Measures

Evaluation of Safety.

Count and percentage of subjects with treatment emergent adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT00728936

First Posted

August 1, 2008

Last Updated

September 28, 2018

Sponsor

Idera Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00728936

Brief Title

Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

Official Title

A Phase 1, Multi-center, Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 in Hepatitis C-infected Patients Unresponsive to Standard Treatment With Pegylated Interferon and Ribavirin

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Idera Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125.

Detailed Description

First-in-humans, phase 1, dose-escalation study with 4 dose levels of single-agent IMO-2125. Patients will proceed through a screening period, treatment period, and follow-up period of approximately 4 months' duration. There will be 4 dose cohorts including active drug and placebo dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C, unresponsive to pegylated interferon and ribavirin therapy, hepatitis C virus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMO-2125 0.04 mg/kg q week

Arm Type

Experimental

Arm Description

IMO-2125 given weekly at 0.04 mg/kg

Arm Title

IMO-2125 0.08 mg/kg q week

Arm Type

Experimental

Arm Description

IMO-2125 given weekly at 0.08 mg/kg

Arm Title

IMO-2125 0.16 mg/kg q week

Arm Type

Experimental

Arm Description

IMO-2125 given weekly at 0.16 mg/kg

Arm Title

IMO-2125 0.32 mg/kg q week

Arm Type

Experimental

Arm Description

IMO-2125 given weekly at 0.32 mg/kg

Arm Title

IMO-2125 0.48 mg/kg q week

Arm Type

Experimental

Arm Description

IMO-2125 given weekly at 0.48 mg/kg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Weekly saline placebo

Arm Title

IMO-2125 0.16 mg/kg twice a week

Arm Type

Experimental

Arm Description

IMO-2125 given twice a week at 0.16 mg/kg

Intervention Type

Drug

Intervention Name(s)

IMO-2125

Intervention Description

IMO-2125 is a synthetic DNA-based agonist of Toll-like receptor 9 (TLR9), TLR9 is expressed in humans in plasmacytoid dendritic cells and B cells of the immune system

Intervention Type

Drug

Intervention Name(s)

Saline placebo

Intervention Description

saline placebo given subcutaneously

Primary Outcome Measure Information:

Title

Evaluation of Safety.

Description

Count and percentage of subjects with treatment emergent adverse events

Time Frame

From screening through study completion, 86 to 115 days in total

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HCV-positive Nonresponder to standard-dose pegylated interferon-α-2a or -α-2b in combination with standard-dose ribavirin Exclusion Criteria: Human immunodeficiency virus (HIV)or hepatitis B surface antigen (HbsAg) Inadequate bone marrow, liver, and renal function Treatment with any IFN (interferon)-based or other experimental or antiviral therapies within 30 days Other significant medical diseases Known alcohol or drug abuse within the past 12 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alice Bexon, MD

Organizational Affiliation

Idera Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Gastoenterstinal Specialist of Georgia, PA

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Henry Ford Med Ctr- Columbus

City

Novi

State/Province

Michigan

ZIP/Postal Code

48377

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

The Liver Institute

City

Dallas

State/Province

Texas

ZIP/Postal Code

75203

Country

United States

Facility Name

Alamo Medical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Fundacion de Investigacion de Diego

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

12. IPD Sharing Statement

Links:

URL

http://iderapharma.com

Description

Related Info

Learn more about this trial

Placebo-controlled, Dose-escalation Study of the Safety of IMO-2125 (Immunomodulatory Oligonucleotide) in Hepatitis C-infected Patients

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