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Completed

NCT Number: NCT00983060

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

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.

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Key information

Conditions

Chronic Hepatitis C Genotype-1 Relapse 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–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Clayton, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIM811

Drug

BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)

Placebo BID + SOC

Drug

Placebo BID + SOC (PEG IFN and RBV)

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. 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

  2. To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC

    Time frame: 4 weeks

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
First posted
Sep 23, 2009
Registry last updated
Dec 19, 2020

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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