Hepatitis CPhase 1NCT00781976
Antiviral Activity of AZD7295 in HCV Carriers
A Phase 1 study testing AZD7295 in people with Hepatitis C, run by Arrow Therapeutics at 1 site in New Zealand.
Trial summary
PK, safety study of AZD7295 in HCV carriers Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- AZD7295
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2008to Mar 2010
- 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
Who may be able to join
- HCV carrier
Who cannot join
- concurrent medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease
PK, safety study of AZD7295 in HCV carriers
- Conditions
- Hepatitis C
- Being tested
- AZD7295, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7295Drug
700mg per day maximum
PlaceboDrug
matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: AZD7295 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma AZD7295 concentrations and pharmacokinetics
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionMar 2010
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrow Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ed Gane, Principal investigator, Auckland Clinical Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781976
- Sponsor's protocol ID
- HCV689-102
- Status last verified
- Mar 2010
- First submitted
- 28 Oct 2008
- Last updated
- 31 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease
- ClinicalTrials.gov ID
- NCT00781976
- Acronym / sponsor ID
- HCV689-102
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Arrow TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Oct 2008 (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.
PK, safety study of AZD7295 in HCV carriers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: AZD7295 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HCV carrier
Key exclusion criteria (1 listed)
- concurrent medications
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 |
|---|---|---|
| AZD7295700mg per day maximum | Drug | 2 |
| Placebomatched placebo | Drug | 1 |
Primary outcome
Plasma AZD7295 concentrations and pharmacokinetics
Time frame: 5 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 31 Mar 2010.
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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.
Ed Gane principal investigator
Auckland Clinical Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7295 in people with Hepatitis C, run by Arrow Therapeutics at 1 site in New Zealand.
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 1 inclusion and 1 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 31 Mar 2010. 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 New Zealand. 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?
Plasma AZD7295 concentrations and pharmacokinetics (time frame: 5 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 31 Mar 2010.