Hepatitis CPhase 1NCT01856426
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
A Phase 1 study testing EDP239 in people with Hepatitis C, run by Enanta Pharmaceuticals, Inc at 5 sites in 2 countries.
Trial summary
The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- EDP239
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2013to Oct 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening.
- Subjects must have chronic HCV infection as determined by any of the following:
- be anti-HCV (+) for at least 6 months per subject history or medical records
- an anti-HCV test, viral load, or genotype > 6 months ago
- In the setting of a recent positive anti-HCV test (< 6 months), liver biopsy demonstrating chronicity
- Subjects must have IL-28b genotype "CC"
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2. BMI = Body weight (kg) / [Height (m)]2
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
- Previous treatment, including the use of any investigational agents, for the treatment of HCV infection.
- Women of child bearing potential.
- Subjects with IL-28b genotype "CT or TT".
- ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN).
- Serum bilirubin must not exceed ULN.
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- The PT (INR) must be within normal limits.
- If necessary, laboratory testing may be repeated on one occasion (as soon as possible) prior to randomization, to rule out any laboratory error.
- Use of drugs that inhibit or induce CYP3A4.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites
Investigative Site
Miami, Florida, 33169
Investigative Site
Murray, Utah, 84123
Investigative Site
San Antonio, Texas, 78215
Germany2 sites
Investigative Site
Frankfurt, 60590
Investigative Site
Hamburg, 20099
About this study
Official title: Double-Blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of Single Doses of EDP239 in Hepatitis C Virus (HCV) Infected Subjects
The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
- Conditions
- Hepatitis C
- Being tested
- EDP239, Placebo
- Keywords
- Hepatitis C infected subjects
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP239Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1- EDP239 | Experimental | EDP239 given once a day. Receives: Drug: EDP239 |
| Placebo | Placebo comparator | 1 treatment arm will be placebo, dose given once a day. Receives: Drug: Placebo |
| 2- EDP239 | Experimental | EDP239 given once a day. Receives: Drug: EDP239 |
| 3-EDP239 | Experimental | EDP239 given once a day. Receives: Drug: EDP239 |
| 4-EDP239 | Experimental | EDP239 given once a day. Receives: Drug: EDP239 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Hepatitis C viral load at Day 1
Blood will be collected for Hepatitis C viral load at Day 1.
Measured: baseline, day 1
Secondary outcomes (3)
Number of participants with adverse events as a measure of safety
Laboratory and clinical evaluations will be used as safety events
Measured: 14 days
Change from baseline in HCV RNA log
A viral load drop in excess of 2.5 will be considered a success.
Measured: baseline, Day 1
Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects
The concentration in plasma parameters of EDP239 will be determined using the actual recorded sampling times and non-compartmental method.
Measured: baseline, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enanta Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enanta Pharmaceuticals, Study director, Enanta Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856426
- Sponsor's protocol ID
- CEDP239X2201
- Status last verified
- Jan 2016
- First submitted
- 14 May 2013
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Wong KA, Jones CT, Jiang L, Lin K, Or YS. Preclinical and Clinical Resistance Profile of EDP-239, a Novel Hepatitis C Virus NS5A Inhibitor. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6216-26. doi: 10.1128/AAC.00815-16. Print 2016 Oct.
PubMed 27503644Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Peng X, Wang C, Ying L, Cao H, Lawitz E, Poordad F, Rondon J, Box TD, Zeuzem S, Buggisch P, Lin K, Qiu YL, Jiang L, Colvin R, Or YS. Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6207-15. doi: 10.1128/AAC.00808-16. Print 2016 Oct.
PubMed 27503640
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo-controlled, Multi-center Trial to Determine the Safety and Antiviral Effect of Single Doses of EDP239 in Hepatitis C Virus (HCV) Infected Subjects
- ClinicalTrials.gov ID
- NCT01856426
- Acronym / sponsor ID
- CEDP239X2201
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C infected subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Enanta Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 May 2013 (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.
The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1- EDP239 | Experimental | Drug: EDP239EDP239 given once a day. |
| Placebo | Placebo comparator | Drug: Placebo1 treatment arm will be placebo, dose given once a day. |
| 2- EDP239 | Experimental | Drug: EDP239EDP239 given once a day. |
| 3-EDP239 | Experimental | Drug: EDP239EDP239 given once a day. |
| 4-EDP239 | Experimental | Drug: EDP239EDP239 given once a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must have chronic genotype-1 hepatitis C virus infection and plasma HCV-RNA ≥ 105 IU/mL at the time of screening.
- Subjects must have chronic HCV infection as determined by any of the following:
- be anti-HCV (+) for at least 6 months per subject history or medical records
- an anti-HCV test, viral load, or genotype > 6 months ago
- In the setting of a recent positive anti-HCV test (< 6 months), liver biopsy demonstrating chronicity
Key exclusion criteria (9 listed)
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days (for small molecules) whichever is longer; or longer if required by local regulations.
- Previous treatment, including the use of any investigational agents, for the treatment of HCV infection.
- Women of child bearing potential.
- Subjects with IL-28b genotype "CT or TT".
- ALT γ-GT, and AST must be below 5 x the upper limit of normal (ULN).
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 |
|---|---|---|
| EDP239 | Drug | 1- EDP239, 2- EDP239, 3-EDP239, 4-EDP239 |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline Hepatitis C viral load at Day 1
Time frame: baseline, day 1
Blood will be collected for Hepatitis C viral load at Day 1.
3 secondary outcomes
Number of participants with adverse events as a measure of safety
Time frame: 14 days
Change from baseline in HCV RNA log
Time frame: baseline, Day 1
Total concentration in plasma of EDP239 in HCV Gentoype 1 infected subjects
Time frame: baseline, day 1
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 29 Jan 2016.
- Derived from this study: PubMed 27503644Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Wong KA, Jones CT, Jiang L, Lin K, Or YS. Preclinical and Clinical Resistance Profile of EDP-239, a Novel Hepatitis C Virus NS5A Inhibitor. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6216-26. doi: 10.1128/AAC.00815-16. Print 2016 Oct.
- Derived from this study: PubMed 27503640Owens CM, Brasher BB, Polemeropoulos A, Rhodin MH, McAllister N, Peng X, Wang C, Ying L, Cao H, Lawitz E, Poordad F, Rondon J, Box TD, Zeuzem S, Buggisch P, Lin K, Qiu YL, Jiang L, Colvin R, Or YS. Preclinical Profile and Clinical Efficacy of a Novel Hepatitis C Virus NS5A Inhibitor, EDP-239. Antimicrob Agents Chemother. 2016 Sep 23;60(10):6207-15. doi: 10.1128/AAC.00808-16. Print 2016 Oct.
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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.
Enanta Pharmaceuticals study director
Enanta Pharmaceuticals, Inc
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP239 in people with Hepatitis C, run by Enanta Pharmaceuticals, Inc at 5 sites in 2 countries.
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 7 inclusion and 9 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany. 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?
Change from baseline Hepatitis C viral load at Day 1 (time frame: baseline, day 1). 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 NCT01856426, which also lists 2 linked publications.
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 29 Jan 2016.