Hepatitis CPhase 2NCT04019717
Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection
A Phase 2 study testing AT-527 and Daclatasvir in people with Hepatitis C and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 3 sites in 3 countries.
Trial summary
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C
- What is being tested?
- AT-527 and Daclatasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 Jun 2019to 23 Mar 2020
- 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
- Body mass index (BMI) of 18-35 kg/m2
- Must agree to use protocol-specified methods of contraception
- Negative pregnancy test
- HCV genotype 1
- Documented history compatible with chronic hepatitis C
- HCV RNA ≥ 10,000 IU/mL at Screening.
- Willing to comply with the study requirements and to provide written informed consent
Who cannot join
- Pregnant or breastfeeding
- Infected with hepatitis B virus or HIV
- Abuse of alcohol or drugs
- Prior exposure to any HCV NS5A inhibitor
- Cirrhosis
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions or contraindications to daclatasvir
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection
- Being tested
- AT-527, Daclatasvir
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527Drug
Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
DaclatasvirDrug
Inhibitor of HCV nonstructural protein 5A (NS5A)
| Study group | Role | What they receive |
|---|---|---|
| 8 weeks | Experimental | Not described Receives: Drug: AT-527; Drug: Daclatasvir |
| 12 weeks | Experimental | Not described Receives: Drug: AT-527; Drug: Daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving sustained virologic response (SVR)
SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Measured: 12 weeks after end of treatment
Incidence of treatment-emergent adverse events
Measured: Through 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start20 Jun 2019
- Primary completion29 Jan 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao-Jian Zhou, PhD, Study director, Atea Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019717
- Sponsor's protocol ID
- AT-01B-002
- Other IDs
- 2019-001431-31, 2019
- Status last verified
- May 2020
- First submitted
- 11 Jul 2019
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic HCV Infection
- ClinicalTrials.gov ID
- NCT04019717
- Acronym / sponsor ID
- AT-01B-002
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 15 Jul 2019 (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.
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will receive 8 or 12 weeks of treatment, based on treatment response.
| Arm | Type | Receives |
|---|---|---|
| 8 weeks | Experimental | Drug: AT-527, Drug: Daclatasvir |
| 12 weeks | Experimental | Drug: AT-527, Drug: Daclatasvir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index (BMI) of 18-35 kg/m2
- Must agree to use protocol-specified methods of contraception
- Negative pregnancy test
- HCV genotype 1
- Documented history compatible with chronic hepatitis C
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding
- Infected with hepatitis B virus or HIV
- Abuse of alcohol or drugs
- Prior exposure to any HCV NS5A inhibitor
- Cirrhosis
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 |
|---|---|---|
| AT-527Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase | Drug | 12 weeks, 8 weeks |
| DaclatasvirInhibitor of HCV nonstructural protein 5A (NS5A) | Drug | 12 weeks, 8 weeks |
Primary outcome
Proportion of subjects achieving sustained virologic response (SVR)
Time frame: 12 weeks after end of treatment
SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Incidence of treatment-emergent adverse events
Time frame: Through 4 weeks after end of treatment
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 4 May 2020.
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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.
Xiao-Jian Zhou, PhD study director
Atea Pharmaceuticals, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-527 and Daclatasvir in people with Hepatitis C and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 3 sites in 3 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 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 4 May 2020. 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 Belgium, Mauritius, Moldova. 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?
Proportion of subjects achieving sustained virologic response (SVR) (time frame: 12 weeks after end of treatment). 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 4 May 2020.