Chronic Hepatitis BPhase 2NCT00040144
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
A Phase 2 study testing ACH126, 433 in people with Chronic Hepatitis B, run by Alexion Pharmaceuticals, Inc. at 18 sites in 3 countries.
Trial summary
The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- ACH126, 433
- How many people
- 85 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Jul 2002to May 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 HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
- On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or
- Achieved an HBV DNA level of < 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to > 100,000 copies/mL HBV DNA, or
- Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
- Hepatitis B e-antigen positive.
- Human immunodeficiency virus (HIV) negative.
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- Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
- Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
- Platelet count >75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
- Serum creatinine < 1.1x the ULN.
- Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
- Prothrombin time/international normalize ratio < 2.
- Participants of reproductive capability must utilize an approved form of birth control.
- All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 international units/liter of beta human chorionic gonadotropin) within 72 hours prior to the start of study medication.
- Participants must be able to provide written informed consent.
- Participant must be available for follow-up for a period of 20 weeks.
Who cannot join
- HIV infection.
- Hepatitis C co-infection.
- Alcohol abuse.
- Pregnancy or breast-feeding.
- Inability to tolerate oral medication.
- Any clinical condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
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- Use of any investigational drug.
- Participants with decompensated liver disease.
- Use of any concomitant herbal treatments.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States13 sites
Clinical Trial Site
Boston, Massachusetts, 02215
Clinical Trial Site
Chicago, Illinois, 60612
Clinical Trial Site
Chicago, Illinois, 60637
Clinical Trial Site
Dallas, Texas, 75246
Clinical Trial Site
Dallas, Texas, 75390
Clinical Trial Site
Fairfax, Virginia, 22031
Clinical Trial Site
Los Angeles, California, 90048
Clinical Trial Site
Miami, Florida, 33136
Clinical Trial Site
New York, New York, 10021
Clinical Trial Site
Orange, California, 92868
Clinical Trial Site
Pasadena, California, 91105
Clinical Trial Site
San Francisco, California, 94143
Clinical Trial Site
Seattle, Washington, 98195
Canada4 sites
Clinical Trial Site
Montreal, Quebec, H2X 3J4
Clinical Trial Site
Toronto, Ontario, M5G 2C4
Clinical Trial Site
Toronto, Ontario, M5T 2S8
Clinical Trial Site
Vancouver, British Columbia, V5Z 1L5
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
Read the detailed description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week treatment in the population is described.
- Conditions
- Chronic Hepatitis B
- Being tested
- ACH126, 433
- Keywords
- E-Antigen Positive, Lamivudine-resistant 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.
ACH126, 433Drug
Also called b-L-Fd4C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2002 (estimated)
- Study startJul 2002
- Study completionMay 2003
Why it stopped: Safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- 85 participants
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
- NCT00040144
- Sponsor's protocol ID
- ACH443-005
- Status last verified
- Feb 2021
- First submitted
- 21 Jun 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, Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT00040144
- Acronym / sponsor ID
- ACH443-005
- Conditions
- Chronic Hepatitis B
- Keywords
- E-Antigen Positive, Lamivudine-resistant Chronic Hepatitis B, Achillion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety concerns
- Enrolment
- 85 participants
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Achillion, a wholly owned subsidiary of Alexion
- Study start
- Jul 2002
- Study completion
- May 2003 (actual)
- First posted
- 25 Jun 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 antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
Detailed description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week 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 (16 listed)
- Chronic HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months
- On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or
- Hepatitis B e-antigen positive.
- Human immunodeficiency virus (HIV) negative.
- Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
Key exclusion criteria (9 listed)
- HIV infection.
- Hepatitis C co-infection.
- Alcohol abuse.
- Pregnancy or breast-feeding.
- Inability to tolerate oral medication.
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 |
|---|---|---|
| ACH126, 433Also: b-L-Fd4C | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Chronic Hepatitis B
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.
18 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 ACH126, 433 in people with Chronic Hepatitis B, run by Alexion Pharmaceuticals, Inc. at 18 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 16 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: stopped early, 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 18 sites in United States, Canada, China. 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 was stopped early (reason given: Safety concerns). 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.
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.