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Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

Primary Purpose

Chronic Hepatitis C Genotype-1 Relapse

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NIM811
Placebo BID + SOC
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Genotype-1 Relapse focused on measuring NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

  • chronic hepatitis C genotype-1
  • HCV-RNA should be ≥ 4 x 105 IU/mL at screening
  • Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit

Exclusion criteria:

  • Use of any HCV treatment ≤ 3months prior to study start
  • Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV
  • Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception
  • Pregnant or breastfeeding women
  • Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection
  • Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets
  • History of treatment for depression
  • Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Research and Education Inc.
  • Orlando Clinical Research Center
  • University Hepatitis Center
  • West Wind'r Research & Development LLC
  • Alamo Medical Research
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Fundacion de Investigacion de Diego
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NIM811

Placebo

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC

Secondary Outcome Measures

To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)

Full Information

First Posted
September 22, 2009
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00983060
Brief Title
Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients
Official Title
A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Genotype-1 Relapse
Keywords
NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIM811
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NIM811
Intervention Description
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Intervention Type
Drug
Intervention Name(s)
Placebo BID + SOC
Intervention Description
Placebo BID + SOC (PEG IFN and RBV)
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks
Time Frame
12 weeks
Title
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
Time Frame
4 weeks
Title
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
Time Frame
3 weeks, 5 weeks
Title
To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12)
Time Frame
12 weeks after cessation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: chronic hepatitis C genotype-1 HCV-RNA should be ≥ 4 x 105 IU/mL at screening Recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment, who subsequently becomes serum HCV RNA positive after stopping treatment ("relapser"). Patients must have been off all treatment for at least 3 months prior to start of study (Visit Exclusion criteria: Use of any HCV treatment ≤ 3months prior to study start Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception Pregnant or breastfeeding women Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets History of treatment for depression Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research and Education Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
University Hepatitis Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
West Wind'r Research & Development LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novartis Investigative Site
City
Clayton
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Novartis Investigative Site
City
Wentworthville
State/Province
South Australia
Country
Australia
Facility Name
Novartis Investigative Site
City
Brussels
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
Country
Spain
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
ROC
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21255610
Citation
Lawitz E, Godofsky E, Rouzier R, Marbury T, Nguyen T, Ke J, Huang M, Praestgaard J, Serra D, Evans TG. Safety, pharmacokinetics, and antiviral activity of the cyclophilin inhibitor NIM811 alone or in combination with pegylated interferon in HCV-infected patients receiving 14 days of therapy. Antiviral Res. 2011 Mar;89(3):238-45. doi: 10.1016/j.antiviral.2011.01.003. Epub 2011 Jan 19.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6083
Description
Results for CNIM811B2202 from the Novartis Clinical Trials website

Learn more about this trial

Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

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