Hepatitis B, ChronicPhase 2NCT00034359
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
A Phase 2 study testing ACH-126,443 and Lamivudine in people with Hepatitis B, Chronic, run by Alexion Pharmaceuticals, Inc. at 3 sites in 2 countries.
Trial summary
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- ACH-126,443 and Lamivudine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2002to Jan 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.
- Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.
- Hepatitis B e-antigen positive.
- Human immunodeficiency virus negative.
- Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).
- No need for excluded medications.
- Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.
Who cannot join
- Human immunodeficiency virus infection.
- Hepatitis C co-infection.
- Concurrent systemic antiviral treatment.
- Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.
- Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
- Alcohol abuse.
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- Pregnancy or breast-feeding.
- Inability to tolerate oral medication.
- Aspartate aminotransferase > 7.0 times the upper limit of normal.
- Alanine aminotransferase > 7.0 times the upper limit of normal.
- Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
- Use of any investigational drug.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Federal Republic of Yugoslavia2 sites
Clinical Trial Site
Belgrade
Clinical Trial Site
Novi Sad
About this study
Official title: A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Read the detailed description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.
- Conditions
- Hepatitis B, Chronic
- Being tested
- ACH-126,443, Lamivudine, Placebo
- Keywords
- E-antigen Positive, Treatment-naive Chronic Hepatitis B, Achillion
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACH-126,443Drug
Also called beta-L-Fd4C
LamivudineDrug
PlaceboDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2002 (estimated)
- Study startFeb 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034359
- Sponsor's protocol ID
- ACH443-003
- Status last verified
- Feb 2021
- First submitted
- 26 Apr 2002
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
- ClinicalTrials.gov ID
- NCT00034359
- Acronym / sponsor ID
- ACH443-003
- Conditions
- Hepatitis B, Chronic
- Keywords
- E-antigen Positive, Treatment-naive Chronic Hepatitis B, Achillion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- Feb 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 29 Apr 2002 (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 was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Detailed description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.
- Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.
- Hepatitis B e-antigen positive.
- Human immunodeficiency virus negative.
- Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).
Key exclusion criteria (12 listed)
- Human immunodeficiency virus infection.
- Hepatitis C co-infection.
- Concurrent systemic antiviral treatment.
- Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.
- Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
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 |
|---|---|---|
| ACH-126,443Also: beta-L-Fd4C | Drug | – |
| Lamivudine | Drug | – |
| Placebo | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACH-126,443 and Lamivudine in people with Hepatitis B, Chronic, run by Alexion Pharmaceuticals, Inc. 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 7 inclusion and 12 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 18 Feb 2021. 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 Federal Republic of Yugoslavia, Bulgaria. 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.
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 18 Feb 2021.