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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03596697
Recruitment Status : Active, not recruiting
First Posted : July 24, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
ContraVir Pharmaceuticals, Inc.

Brief Summary:
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.

Condition or disease Intervention/treatment Phase
Hepatitis B Infectious Disease Liver Diseases Drug: CRV431 Drug: Placebo Drug: TDF Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in HBV-Infected Subjects on Chronic Tenofovir Disoproxil Fumarate Treatment
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CRV431
Either single or multiple doses of varying dose levels
Drug: CRV431
Single or multiple dose(s) of CRV431

Placebo Comparator: Placebo Drug: Placebo
Single Placebo dose

Experimental: TDF
300 mg TDF
Drug: TDF
Single or multiple dose(s) of TDF




Primary Outcome Measures :
  1. Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events [ Time Frame: 56 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Capable of giving written informed consent
  • Willing and able to complete all study requirements
  • Healthy male or female between 18 and 55 years of age (inclusive);
  • Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria:

  • Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
  • Current or history of abuse of alcohol or illicit drugs
  • Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

  • Evidence of significant liver fibrosis or cirrhosis
  • History of NAFLD or NASH
  • Positive test for HDV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596697


Locations
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United States, Arizona
Celerion, Inc
Tempe, Arizona, United States, 85283
United States, California
Axis Clinical Trials
Los Angeles, California, United States, 90036
United States, Florida
Schiff Center for Liver Diseases, University of Miami
Miami, Florida, United States, 33136
United States, Nebraska
Celerion, Inc
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
ContraVir Pharmaceuticals, Inc.
Investigators
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Study Director: Michael Snyder ContraVir Pharmaceutical, Inc.

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Responsible Party: ContraVir Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03596697     History of Changes
Other Study ID Numbers: CTRV-CRV431-101
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ContraVir Pharmaceuticals, Inc.:
CRV431
Hepatitis B Virus
Hepatitis Virus

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Communicable Diseases
Infection
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents