Chronic Hepatitis CPhase 1/2CP104NCT00522808
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers
A Phase 1/2 study testing A-831 in people with Chronic Hepatitis C, run by Arrow Therapeutics at 3 sites in 2 countries.
Trial summary
The purposes of this study are: to determine the safety and tolerability of multiple doses of A-831 at various doses to determine how multiple doses of A-831 are distributed through the bloodstream to determine if A-831 reduces the amount of Hepatitis C virus in the blood Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- A-831
- How many people
- 36 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Aug 2007to May 2008
- Phase
- Phase 1/2
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
- Volunteers who have given their written informed consent to participate in the study
- Volunteers who are willing and able to comply with the protocol and study procedures
- Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)
Who cannot join
- Voulnteers with concurrent medical conditions or taking concurrent medications
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Birmingham WTCRF
Birmingham, B15 2TH
DDS
Dundee, DD1 9SY
About this study
Official title: A Clinical Pharmacology Study to Determine the Pharmacokinetic , Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of A-831 in Otherwise Healthy Male Hepatitis C Carriers With Compensated Liver Disease
The purposes of this study are:
- to determine the safety and tolerability of multiple doses of A-831 at various doses
- to determine how multiple doses of A-831 are distributed through the bloodstream
- to determine if A-831 reduces the amount of Hepatitis C virus in the blood
- Conditions
- Chronic Hepatitis C
- Being tested
- A-831
- Keywords
- HCV, antiviral, PK, Safety
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-831Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
PK
Tolerability
Antiviral activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2008
- Study completionMay 2008
Why it stopped: Need for re-formulation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrow Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DDS, Dundee, David Mutimer, Birmingham, Ed Gane, ACS New Zealand
- Investigators
- Brian Sanderson, Principal investigator, DDSDavid Mutimer, Principal investigator, WTCRF BirminghamEdward Gane, Principal investigator, ACS New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522808
- Sponsor's protocol ID
- CP104
- Acronym
- CP104
- Status last verified
- Sep 2008
- First submitted
- 29 Aug 2007
- Last updated
- 29 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study to Determine the Pharmacokinetic , Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of A-831 in Otherwise Healthy Male Hepatitis C Carriers With Compensated Liver Disease
- ClinicalTrials.gov ID
- NCT00522808
- Acronym / sponsor ID
- CP104 / CP104
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV, antiviral, PK, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Need for re-formulation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Arrow TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- DDS, Dundee, David Mutimer, Birmingham, Ed Gane, ACS New Zealand
- Study start
- Aug 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Aug 2007 (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 purposes of this study are:
- to determine the safety and tolerability of multiple doses of A-831 at various doses
- to determine how multiple doses of A-831 are distributed through the bloodstream
- to determine if A-831 reduces the amount of Hepatitis C virus in the blood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
- Volunteers who have given their written informed consent to participate in the study
- Volunteers who are willing and able to comply with the protocol and study procedures
- Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)
Key exclusion criteria (1 listed)
- Voulnteers with concurrent medical conditions or taking 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 |
|---|---|---|
| A-831 | Drug | – |
Primary outcome
Safety
PK
Tolerability
Antiviral activity
Results and safety
The study was stopped early (reason given: Need for re-formulation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2008.
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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.
Brian Sanderson principal investigator
DDS
David Mutimer principal investigator
WTCRF Birmingham
Edward Gane principal investigator
ACS New Zealand
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A-831 in people with Chronic Hepatitis C, run by Arrow Therapeutics at 3 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 4 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: stopped early, as of the sponsor's last update on 29 Sep 2008. 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 Kingdom, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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 was stopped early (reason given: Need for re-formulation). Results are not available in the source record.
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?
Safety. The study lists 4 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 29 Sep 2008.