Infectious DiseasePhase 2NCT02710604
Phase 2, Multiple Ascending Dose Proof of Concept Study
A Phase 2 study testing CMX157 and TDF in people with Infectious Disease, run by ContraVir Pharmaceuticals, Inc. at 1 site in Thailand.
Trial summary
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infectious Disease
- What is being tested?
- CMX157 and TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteThailand
- Study dates
- May 2016to 18 Jul 2017
- Phase
- Phase 2
- 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
Who may be able to join
- Capable of giving written informed consent.
- Capable of completing study requirements.
- Chronic hepatitis B positive.
- HBV treatment naïve.
Who cannot join
- Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
- History or medical condition that could impact patient safety.
- Current or past abuse of alcohol or illicit drugs.
- Abnormal laboratory value or ECG.
- Pregnant or breastfeeding.
- Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.
- Systemic immunosuppression.
- Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Read the detailed description
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.
- Conditions
- Infectious Disease
- Being tested
- CMX157, TDF
- Keywords
- chronic hepatitis B(CHB)
- Medical subject headings
- Communicable Diseases, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMX157Drug
Also called lipid conjugate TFV(tenofovir)
tablet
TDFDrug
Also called tenofovir disoproxil fumerate
300mg tablet
| Study group | Role | What they receive |
|---|---|---|
| CMX157 5mg versus TDF | Active comparator | CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days Receives: Drug: CMX157; Drug: TDF |
| CMX157 10mg versus TDF | Active comparator | CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days Receives: Drug: CMX157; Drug: TDF |
| CMX157 25mg versus TDF | Active comparator | CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days Receives: Drug: CMX157; Drug: TDF |
| CMX157 50mg versus TDF | Active comparator | CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days Receives: Drug: CMX157; Drug: TDF |
| CMX157 100mg versus TDF | Active comparator | CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days Receives: Drug: CMX157; Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
Capture adverse events, physical examinations, ECGs and clinical laboratory panels
Measured: 28 days
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
HBV DNA levels
Measured: 28 days
Secondary outcomes (4)
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.
Measuring Cmax(concentration maximum): the peak plasma concentration.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.
Measuring Tmax(time maximum): the time Cmax was observed.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.
Measuring AUC(area under the curve): area under plasma concentration versus time curve.
Measured: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.
Measuring Cmin(concentration minimum): minimum observed plasma concentration.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion18 Jul 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sullivan-Boylai, MD, Study chair, ContraVir Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710604
- Sponsor's protocol ID
- CTRV-CMX157-201
- Status last verified
- Dec 2016
- First submitted
- 14 Mar 2016
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-label, Ascending, Sequential Dose Group, Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of CMX157 in HBV-infected Subjects
- ClinicalTrials.gov ID
- NCT02710604
- Acronym / sponsor ID
- CTRV-CMX157-201
- Conditions
- Infectious Disease
- Keywords
- chronic hepatitis B(CHB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- ContraVir Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 18 Jul 2017 (actual)
- First posted
- 17 Mar 2016 (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 is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.
Detailed description
This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels in hepatitis B virus(HBV) infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CMX157 5mg versus TDF | Active comparator | Drug: CMX157, Drug: TDFCMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days |
| CMX157 10mg versus TDF | Active comparator | Drug: CMX157, Drug: TDFCMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days |
| CMX157 25mg versus TDF | Active comparator | Drug: CMX157, Drug: TDFCMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days |
| CMX157 50mg versus TDF | Active comparator | Drug: CMX157, Drug: TDFCMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days |
| CMX157 100mg versus TDF | Active comparator | Drug: CMX157, Drug: TDFCMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Capable of giving written informed consent.
- Capable of completing study requirements.
- Chronic hepatitis B positive.
- HBV treatment naïve.
Key exclusion criteria (8 listed)
- Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
- History or medical condition that could impact patient safety.
- Current or past abuse of alcohol or illicit drugs.
- Abnormal laboratory value or ECG.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| CMX157Also: lipid conjugate TFV(tenofovir)tablet | Drug | CMX157 100mg versus TDF, CMX157 10mg versus TDF, CMX157 25mg versus TDF, CMX157 50mg versus TDF, CMX157 5mg versus TDF |
| TDFAlso: tenofovir disoproxil fumerate300mg tablet | Drug | CMX157 100mg versus TDF, CMX157 10mg versus TDF, CMX157 25mg versus TDF, CMX157 50mg versus TDF, CMX157 5mg versus TDF |
Primary outcome
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients
Time frame: 28 days
Capture adverse events, physical examinations, ECGs and clinical laboratory panels
To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).
Time frame: 28 days
HBV DNA levels
4 secondary outcomes
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.
Time frame: 28 days
Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.
Time frame: 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 13 Sep 2017.
- Individual participant dataSharing planned: Yes
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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.
John Sullivan-Boylai, MD study chair
ContraVir Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CMX157 and TDF in people with Infectious Disease, run by ContraVir Pharmaceuticals, Inc. at 1 site in Thailand.
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 8 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients (time frame: 28 days). The study lists 2 primary outcomes in all. 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 13 Sep 2017.