Chronic Hepatitis B Virus TreatmentNCT01548820
Resistance to Lamivudine in HBV Egyptian Patients
An observational study of Chronic Hepatitis B Virus Treatment, run by Ain Shams University at 1 site in Egypt.
Trial summary
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B Virus Treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2010to Jan 2013
- Phase
- Observational
- 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
Study population: chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.
Who may be able to join
- Adult patients >18 years old
- Egyptian nationality
- Positive serology for HBsAg for more than 6 months
- Positive HBV viremia (above 2000IU/ml).
- Lamivudine monotherapy
Who cannot join
- Anti-HBcIgM seropositivity
- Positive serology for HCV
- Positive serology for HDV
- Patients complicated with HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients
Read the detailed description
Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:
- ALT.
- HBeAg.
- HBV-DNA by quantitative PCR.
- Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.
- Conditions
- Chronic Hepatitis B Virus Treatment
- Keywords
- Hepatitis B virus, Lamivudine, Resistance to treatment
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic HBV Egyptian patients | chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resistance to Lamivudine Therapy
Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionNov 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus TreatmentStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548820
- Sponsor's protocol ID
- HBV resistance
- Status last verified
- Sep 2013
- First submitted
- 6 Mar 2012
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
- ClinicalTrials.gov ID
- NCT01548820
- Acronym / sponsor ID
- HBV resistance
- Conditions
- Chronic Hepatitis B Virus Treatment
- Keywords
- Hepatitis B virus, Lamivudine, Resistance to treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Mar 2012 (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.
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients
Detailed description
Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:
- ALT.
- HBeAg.
- HBV-DNA by quantitative PCR.
- Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic HBV Egyptian patients | – | –chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.
Key inclusion criteria (5 listed)
- Adult patients >18 years old
- Egyptian nationality
- Positive serology for HBsAg for more than 6 months
- Positive HBV viremia (above 2000IU/ml).
- Lamivudine monotherapy
Key exclusion criteria (4 listed)
- Anti-HBcIgM seropositivity
- Positive serology for HCV
- Positive serology for HDV
- Patients complicated with HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resistance to Lamivudine Therapy
Time frame: 1 year
Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance
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 10 Sep 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Virus Treatment, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 4 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 10 Sep 2013. 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 Egypt. 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.
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?
Resistance to Lamivudine Therapy (time frame: 1 year). 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 10 Sep 2013.