Hepatitis B, ChronicPhase 2NCT00230503
Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
A Phase 2 study testing pradefovir mesylate and adefovir dipivoxyl in people with Hepatitis B, Chronic, run by Bausch Health Americas, Inc..
Trial summary
Compare the safety of four oral doses of pradefovir after 48 weeks of treatment Select the dose of pradefovir for Phase 3 studies Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- pradefovir mesylate and adefovir dipivoxyl
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Dec 2006
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Compensated chronic HBV Infection
- No prior treatment with adefovir dipivoxil
- No interferon or lamivudine treatment for three months prior to enrollment
- HBeAg positive or negative
- HBV DNA viral load greater than 500,000 copies per mL
- ALT between 1.2 and 10 times ULN
Who cannot join
- Positive HIV, HCV, and/or HDV serology
- History of renal tubular necrosis
- Serum creatinine greater than 2.0 mg/dl
- History of organ transplant or use of immunosuppresive drugs
- Pregnant or breast-feeding females
About this study
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
Read the detailed description
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
- Determine the pharacokinetic profiles of four oral doses of pradefovir
- Conditions
- Hepatitis B, Chronic
- Being tested
- pradefovir mesylate, adefovir dipivoxyl
- Keywords
- Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pradefovir mesylateDrug
adefovir dipivoxylDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time
Secondary outcomes (1)
- Efficacy: Proportion of patients with undetectable viral load
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, 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
- None (open label)
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph T. Doyle, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230503
- Sponsor's protocol ID
- RNA200103-201
- Status last verified
- Jun 2012
- First submitted
- 28 Sep 2005
- Last updated
- 22 Jun 2012
- Results posted
- No
Publications
Gao Y, Kong F, Song X, Shang J, Yao L, Xia J, Peng Y, Liu W, Gong H, Mu M, Cui H, Han T, Chen W, Wu X, Yang Y, Yan X, Jin Z, Wang P, Zhu Q, Chen L, Zhao C, Zhang D, Jin W, Wang D, Wen X, Liu C, Jia J, Mao Q, Ding Y, Jin X, Zhang Z, Mao Q, Li G, Niu J. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial. Clin Infect Dis. 2022 Jun 10;74(11):1925-1932. doi: 10.1093/cid/ciab763.
PubMed 34487151
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B
- ClinicalTrials.gov ID
- NCT00230503
- Acronym / sponsor ID
- RNA200103-201
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, Chronic, Hepatitis B Virus, Pradefovir Mesylate, Adefovir Dipivoxyl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Sep 2005 (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.
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
Detailed description
- Compare the safety of four oral doses of pradefovir after 48 weeks of treatment
- Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment
- Select the dose of pradefovir for Phase 3 studies
- Determine the pharacokinetic profiles of four oral doses of pradefovir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Compensated chronic HBV Infection
- No prior treatment with adefovir dipivoxil
- No interferon or lamivudine treatment for three months prior to enrollment
- HBeAg positive or negative
- HBV DNA viral load greater than 500,000 copies per mL
Key exclusion criteria (5 listed)
- Positive HIV, HCV, and/or HDV serology
- History of renal tubular necrosis
- Serum creatinine greater than 2.0 mg/dl
- History of organ transplant or use of immunosuppresive drugs
- Pregnant or breast-feeding females
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 |
|---|---|---|
| pradefovir mesylate | Drug | – |
| adefovir dipivoxyl | Drug | – |
Primary outcome
- Safety: Clinical examinations of laboratory tests
- Efficacy: Change in viral load over time
1 secondary outcome
- Efficacy: Proportion of patients with undetectable viral load
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 22 Jun 2012.
- Derived from this study: PubMed 34487151Gao Y, Kong F, Song X, Shang J, Yao L, Xia J, Peng Y, Liu W, Gong H, Mu M, Cui H, Han T, Chen W, Wu X, Yang Y, Yan X, Jin Z, Wang P, Zhu Q, Chen L, Zhao C, Zhang D, Jin W, Wang D, Wen X, Liu C, Jia J, Mao Q, Ding Y, Jin X, Zhang Z, Mao Q, Li G, Niu J. Pradefovir Treatment in Patients With Chronic Hepatitis B: Week 24 Results From a Multicenter, Double-Blind, Randomized, Noninferiority, Phase 2 Trial. Clin Infect Dis. 2022 Jun 10;74(11):1925-1932. doi: 10.1093/cid/ciab763.
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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.
Ralph T. Doyle study director
Bausch Health Americas, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pradefovir mesylate and adefovir dipivoxyl in people with Hepatitis B, Chronic, run by Bausch Health Americas, Inc..
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 6 inclusion and 5 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
- Safety: Clinical examinations of laboratory tests. 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?
On the ClinicalTrials.gov record for NCT00230503, which also lists 1 linked publication.
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 22 Jun 2012.