Hepatitis BPhase 1NCT03596697
A Study in Healthy Volunteers
A Phase 1 study testing CRV431 and TDF in people with Hepatitis B and Infectious Disease, run by Hepion Pharmaceuticals, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Infectious Disease, Liver Diseases
- What is being tested?
- CRV431 and TDF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jul 2019to 4 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Celerion, Inc
Lincoln, Nebraska, 68502
Pinnacle Clinical Research
San Antonio, Texas, 78229
Celerion, Inc
Tempe, Arizona, 85283
About this study
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 Healthy Volunteer Subjects
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.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Being tested
- CRV431, Placebo, TDF
- Keywords
- CRV431, Hepatitis B Virus, Hepatitis Virus
- Medical subject headings
- Hepatitis B, Communicable Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRV431Drug
Single or multiple dose(s) of CRV431
PlaceboDrug
Single Placebo dose
TDFDrug
Single or multiple dose(s) of TDF
| Study group | Role | What they receive |
|---|---|---|
| CRV431 | Experimental | Either single or multiple doses of varying dose levels Receives: Drug: CRV431 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| TDF | Experimental | 300 mg TDF Receives: Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start9 Jul 2019
- Primary completion30 Sep 2020
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jill Greytok, Study director, ContraVir Pharmaceutical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596697
- Sponsor's protocol ID
- CTRV-CRV431-101
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2018
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Healthy Volunteer Subjects
- ClinicalTrials.gov ID
- NCT03596697
- Acronym / sponsor ID
- CTRV-CRV431-101
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Keywords
- CRV431, Hepatitis B Virus, Hepatitis Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hepion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 24 Jul 2018 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRV431 | Experimental | Drug: CRV431Either single or multiple doses of varying dose levels |
| Placebo | Placebo comparator | Drug: Placebo |
| TDF | Experimental | Drug: TDF300 mg TDF |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (7 listed)
- 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.
- Evidence of significant liver fibrosis or cirrhosis
- History of NAFLD or NASH
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 |
|---|---|---|
| CRV431Single or multiple dose(s) of CRV431 | Drug | CRV431 |
| PlaceboSingle Placebo dose | Drug | Placebo |
| TDFSingle or multiple dose(s) of TDF | Drug | TDF |
Primary outcome
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
Time frame: 56 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 1 Dec 2021.
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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.
Jill Greytok study director
ContraVir Pharmaceutical, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CRV431 and TDF in people with Hepatitis B and Infectious Disease, run by Hepion Pharmaceuticals, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2021.