ThrombocytopeniaNCT01987791
Observation Study of Prednisone and Cyclosporine in Treatment of Thrombocytopenia in Hepatitis B Cirrhosis
An observational study of Thrombocytopenia and Hepatitis B, run by Peking University People's Hospital.
Trial summary
To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombocytopenia, Hepatitis B, Cirrhosis
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.
Who may be able to join
- diagnosed HBV-associated cirrhosis
- had an serum HBV DNA level of more than 500 IU per milliliter
- have compensated liver cirrhosis
- thrombocytopenia (defined as a platelet count of <30,000 per cubic millimeter)
- accompanied with bleed tendency (including petechial, episxias, ecchymosis, hemoptysis, hematemesis and hematochezia)
- have a liver-biopsy specimen indicative of cirrhosis, ultrasonography and/or computed tomographic imaging evidence of cirrhosis, or endoscopic evidence of portal hypertension(splenomegaly, ascites, and esophageal varicose)
Who cannot join
- pregnant
- hepatocellular carcinoma
- decompensated cirrhosis
- coagulation function abnormal
- had a history of other disease (e.g. aplastic anemia, autoimmune disease, idiopathic thrombocytopenia et al) that could induced thrombocytopenia
- co-infected with the human immunodeficiency virus
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- co-infected with hepatitis C virus
- co-infected with hepatitis D virus
- had a coexisting serious medical or psychiatric illness
- serum creatinine level was more than 1.5 times the upper limit of the normal range
About this study
Official title: Comparison of Prednisone and Cyclosporine in the Treatment of Thrombocytopenia in Patients With Cirrhosis Associated With Hepatitis B in China: a Collaborative, Open-label, Real World Observational Study
To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.
- Conditions
- Thrombocytopenia, Hepatitis B, Cirrhosis
- Medical subject headings
- Thrombocytopenia, Hepatitis B, Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure
The primary efficacy outcome was treatment failure, defined as the composite of (1) any platelet count below 50×109/L after four weeks treatment; (2) significant bleeding, defined as grade 2 severity from any anatomical site as per the ITP bleeding scale that defines bleed grades (0, none; 1, mild; or 2, marked) by objective criteria of 9, based on events that occurred since the last study visit; or (3) rescue treatment administered because of severe thrombocytopenia, bleeding, or a planned invasive procedure.
Measured: 12 months
Secondary outcomes (2)
proportion of patients with a complete platelet count response
Secondary end points included proportion of patients with a complete platelet count response (platelet count of ≥ 100×109/L) without rescue treatment at 4 weeks, at 6 months , and at 12 months
Measured: at 4 weeks, at 6 months , and at 12 months
proportion of patients with an overall platelet count response
Secondary end points included proportion of patients with an overall platelet count response (platelet count of ≥ 30×109/L with doubling from baseline) without rescue treatment at 4 weeks, at 6 months , and at 12 months
Measured: at 4 weeks, at 6 months , and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2005
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987791
- Sponsor's protocol ID
- HBV-PLT-100
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prednisone and Cyclosporine in the Treatment of Thrombocytopenia in Patients With Cirrhosis Associated With Hepatitis B in China: a Collaborative, Open-label, Real World Observational Study
- ClinicalTrials.gov ID
- NCT01987791
- Acronym / sponsor ID
- HBV-PLT-100
- Conditions
- Thrombocytopenia, Hepatitis B, Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Nov 2013 (actual)
- First posted
- 19 Nov 2013 (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.
To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.
Key inclusion criteria (6 listed)
- diagnosed HBV-associated cirrhosis
- had an serum HBV DNA level of more than 500 IU per milliliter
- have compensated liver cirrhosis
- thrombocytopenia (defined as a platelet count of <30,000 per cubic millimeter)
- accompanied with bleed tendency (including petechial, episxias, ecchymosis, hemoptysis, hematemesis and hematochezia)
Key exclusion criteria (10 listed)
- pregnant
- hepatocellular carcinoma
- decompensated cirrhosis
- coagulation function abnormal
- had a history of other disease (e.g. aplastic anemia, autoimmune disease, idiopathic thrombocytopenia et al) that could induced thrombocytopenia
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
treatment failure
Time frame: 12 months
The primary efficacy outcome was treatment failure, defined as the composite of (1) any platelet count below 50×109/L after four weeks treatment; (2) significant bleeding, defined as grade 2 severity from any anatomical site as per the ITP bleeding scale that defines bleed grades (0, none; 1, mild; or 2, marked) by objective criteria of 9, based on events that occurred since the last study visit; or (3) rescue treatment administered because of severe thrombocytopenia, bleeding, or a planned invasive procedure.
2 secondary outcomes
proportion of patients with a complete platelet count response
Time frame: at 4 weeks, at 6 months , and at 12 months
proportion of patients with an overall platelet count response
Time frame: at 4 weeks, at 6 months , and at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Hepatitis B, run by Peking University People's Hospital.
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 10 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: status not confirmed, as of the sponsor's last update on 19 Nov 2013. 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.
Are results available for this study?
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?
treatment failure (time frame: 12 months). 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 19 Nov 2013.