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Trial record 85 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients

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ClinicalTrials.gov Identifier: NCT02401737
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novira Therapeutics, Inc.

Brief Summary:
This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: NVR 3-778 Drug: Placebo for NVR 3-778 Drug: Pegasys Phase 1

Detailed Description:

The Phase 1b assessments of the dose-related safety, PK, and initial antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B patients.

To promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or placebo doses), for all treatment cohorts in the study. Study advancement to subsequent patient cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol. Also, there will be one interim review of safety data by an independent Safety Monitoring Board (SMB), as described in the protocol.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1b Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Initial Antiviral Efficacy of NVR 3-778 in Patients With HBeAg-Positive Chronic Hepatitis B Virus Infection
Actual Study Start Date : January 31, 2015
Actual Primary Completion Date : May 18, 2016
Actual Study Completion Date : May 18, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NVR 3-778
NVR 3-778 in varying doses of capsules by mouth for 28 days
Drug: NVR 3-778
Placebo Comparator: Placebo for NVR 3-778
Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days
Drug: Placebo for NVR 3-778
Sugar pill manufactured to mimic the NVR 3-778 capsule

Experimental: NVR 3-778 and Pegasys
NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days
Drug: NVR 3-778
Drug: Pegasys
Other Name: peginterferon alfa-2a

Active Comparator: Pegasys
Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days
Drug: Pegasys
Other Name: peginterferon alfa-2a




Primary Outcome Measures :
  1. Compared with baseline, decline of serum HBV-DNA in the value [ Time Frame: Up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must be HBeAg positive and have chronic hepatitis B with no history of clinical decompensation.

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): NCT02401737


Locations
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United States, California
Costa Mesa, California, United States
Pasadena, California, United States
San Diego, California, United States
San Francisco, California, United States
China
Hong Kong, China
Korea, Republic of
Chuncheon, Korea, Republic of
Seongnam, Korea, Republic of
Singapore
Singapore, Singapore
Taiwan
Kaohsiung, Taiwan
Keelung, Taiwan
Sponsors and Collaborators
Novira Therapeutics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02401737     History of Changes
Other Study ID Numbers: NVR3-778-101B
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

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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 Novira Therapeutics, Inc.:
Hepatitis B
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
DNA Virus Infections
Peginterferon alfa-2a
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
Antiviral Agents
Interferon-alpha
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs