Chronic Hepatitis BPhase 1NCT02401737
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients
A Phase 1 study testing NVR 3-778 and Pegasys in people with Chronic Hepatitis B, run by Novira Therapeutics, Inc. at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- NVR 3-778 and Pegasys
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 31 Jan 2015to 18 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United States4 sites
Study site
Costa Mesa, California
Study site
Pasadena, California
Study site
San Diego, California
Study site
San Francisco, California
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- NVR 3-778, Placebo for NVR 3-778, Pegasys
- Keywords
- Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVR 3-778Drug
Placebo for NVR 3-778Drug
Sugar pill manufactured to mimic the NVR 3-778 capsule
PegasysDrug
Also called peginterferon alfa-2a
| Study group | Role | What they receive |
|---|---|---|
| NVR 3-778 | Experimental | NVR 3-778 in varying doses of capsules by mouth for 28 days Receives: Drug: NVR 3-778 |
| Placebo for NVR 3-778 | Placebo comparator | Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days Receives: Drug: Placebo for NVR 3-778 |
| NVR 3-778 and Pegasys | Experimental | NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days Receives: Drug: NVR 3-778; Drug: Pegasys |
| Pegasys | Active comparator | Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days Receives: Drug: Pegasys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with baseline, decline of serum HBV-DNA in the value
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start31 Jan 2015
- Primary completion18 May 2016
- Study completion18 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novira Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401737
- Sponsor's protocol ID
- NVR3-778-101B
- Status last verified
- Oct 2017
- First submitted
- 11 Mar 2015
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yuen MF, Gane EJ, Kim DJ, Weilert F, Yuen Chan HL, Lalezari J, Hwang SG, Nguyen T, Flores O, Hartman G, Liaw S, Lenz O, Kakuda TN, Talloen W, Schwabe C, Klumpp K, Brown N. Antiviral Activity, Safety, and Pharmacokinetics of Capsid Assembly Modulator NVR 3-778 in Patients with Chronic HBV Infection. Gastroenterology. 2019 Apr;156(5):1392-1403.e7. doi: 10.1053/j.gastro.2018.12.023. Epub 2019 Jan 6.
PubMed 30625297
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02401737
- Acronym / sponsor ID
- NVR3-778-101B
- Conditions
- Chronic Hepatitis B
- Keywords
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Novira Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2015 (actual)
- Primary completion
- 18 May 2016 (actual)
- Study completion
- 18 May 2016 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NVR 3-778 | Experimental | Drug: NVR 3-778NVR 3-778 in varying doses of capsules by mouth for 28 days |
| Placebo for NVR 3-778 | Placebo comparator | Drug: Placebo for NVR 3-778Placebo for NVR 3-778 in varying doses of capsules by mouth for 28 days |
| NVR 3-778 and Pegasys | Experimental | Drug: NVR 3-778, Drug: PegasysNVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days |
| Pegasys | Active comparator | Drug: PegasysPegasys alone in a yet to be determined dose by subcutaneous injection for 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVR 3-778 | Drug | NVR 3-778, NVR 3-778 and Pegasys |
| Placebo for NVR 3-778Sugar pill manufactured to mimic the NVR 3-778 capsule | Drug | Placebo for NVR 3-778 |
| PegasysAlso: peginterferon alfa-2a | Drug | NVR 3-778 and Pegasys, Pegasys |
Primary outcome
Compared with baseline, decline of serum HBV-DNA in the value
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Derived from this study: PubMed 30625297Yuen MF, Gane EJ, Kim DJ, Weilert F, Yuen Chan HL, Lalezari J, Hwang SG, Nguyen T, Flores O, Hartman G, Liaw S, Lenz O, Kakuda TN, Talloen W, Schwabe C, Klumpp K, Brown N. Antiviral Activity, Safety, and Pharmacokinetics of Capsid Assembly Modulator NVR 3-778 in Patients with Chronic HBV Infection. Gastroenterology. 2019 Apr;156(5):1392-1403.e7. doi: 10.1053/j.gastro.2018.12.023. Epub 2019 Jan 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NVR 3-778 and Pegasys in people with Chronic Hepatitis B, run by Novira Therapeutics, Inc. at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, South Korea, Taiwan, China, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared with baseline, decline of serum HBV-DNA in the value (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.