Hemoglobinuria, ParoxysmalNCT01224483
Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
An observational study of Hemoglobinuria, Paroxysmal, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hemoglobinuria, Paroxysmal
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2010
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Korean PNH patients: diagnosis confirmed by Ham's test or Flow cytometry
Who may be able to join
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
Who cannot join
- Patients have no Flow cytometry data
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Hematology Oncology, Samsung Medical Center
Seoul, 135-710
Jun Ho Jang, M.D., 82-2-3410-0918, smcjunhojang@gmail.com
About this study
Official title: Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH
Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.
Read the detailed description
To evaluate the clinical characteristics in Korean PNH patients
- Conditions
- Hemoglobinuria, Paroxysmal
- Medical subject headings
- Hemoglobinuria, Paroxysmal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemoglobinuria, ParoxysmalStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jun Ho Jang, M.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224483
- Sponsor's protocol ID
- 2010-02-048
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK, Lee JW. Predictive Factors of Mortality in Population of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Results from a Korean PNH Registry. J Korean Med Sci. 2016 Feb;31(2):214-21. doi: 10.3346/jkms.2016.31.2.214. Epub 2016 Jan 26.
PubMed 26839475Kim JS, Jang JH, Yoon SS, Lee JH, Kim YK, Jo DY, Chung JS, Sohn SK, Lee JW. Distinct subgroups of paroxysmal nocturnal hemoglobinuria (PNH) with cytopenia: results from South Korean National PNH Registry. Ann Hematol. 2016 Jan;95(1):125-133. doi: 10.1007/s00277-015-2511-z. Epub 2015 Sep 29.
PubMed 26416513Lee JW, Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK. Clinical signs and symptoms associated with increased risk for thrombosis in patients with paroxysmal nocturnal hemoglobinuria from a Korean Registry. Int J Hematol. 2013 Jun;97(6):749-57. doi: 10.1007/s12185-013-1346-4. Epub 2013 May 1.
PubMed 23636668
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Analysis About the Clinical Characteristics of Korean Patients With PNH
- ClinicalTrials.gov ID
- NCT01224483
- Acronym / sponsor ID
- 2010-02-048
- Conditions
- Hemoglobinuria, Paroxysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 20 Oct 2010 (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.
Paroxysmal nocturnal hemoglobinuria (PNH) is a hematopoietic stem cell disorder in which unregulated activation of the complement system leads to significant ischemic morbidities with shortened lifespan. Life-threatening thromboembolism (TE) is the most feared complication of PNH, accounting for up to 45% of patient deaths. It is estimated that 40% of PNH patients experience a clinically evident TE and 60% of patients without clinically diagnosed TE demonstrate TE by high-sensitivity MRI, indicating the ongoing thrombotic risk in most patients with PNH. Much of these data come from PNH patients from European descent. To understand the impact of TE in patients with PNH from non-European regions, we performed this study to evaluate the clinical characteristics of Korean patients with PNH.
Detailed description
To evaluate the clinical characteristics in Korean PNH patients
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Korean PNH patients: diagnosis confirmed by Ham's test or Flow cytometry
Key inclusion criteria (1 listed)
- Diagnosis confirmed by Ham's test or Flow cytometry Patients have any Flow cytometry data
Key exclusion criteria (1 listed)
- Patients have no Flow cytometry data
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Derived from this study: PubMed 26839475Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK, Lee JW. Predictive Factors of Mortality in Population of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Results from a Korean PNH Registry. J Korean Med Sci. 2016 Feb;31(2):214-21. doi: 10.3346/jkms.2016.31.2.214. Epub 2016 Jan 26.
- Derived from this study: PubMed 26416513Kim JS, Jang JH, Yoon SS, Lee JH, Kim YK, Jo DY, Chung JS, Sohn SK, Lee JW. Distinct subgroups of paroxysmal nocturnal hemoglobinuria (PNH) with cytopenia: results from South Korean National PNH Registry. Ann Hematol. 2016 Jan;95(1):125-133. doi: 10.1007/s00277-015-2511-z. Epub 2015 Sep 29.
- Derived from this study: PubMed 23636668Lee JW, Jang JH, Kim JS, Yoon SS, Lee JH, Kim YK, Jo DY, Chung J, Sohn SK. Clinical signs and symptoms associated with increased risk for thrombosis in patients with paroxysmal nocturnal hemoglobinuria from a Korean Registry. Int J Hematol. 2013 Jun;97(6):749-57. doi: 10.1007/s12185-013-1346-4. Epub 2013 May 1.
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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.
Division of Hematology Oncology, Samsung Medical Center
Seoul, South Korea
Jun Ho Jang, M.D. principal investigator
Samsung Medical Center
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 Hemoglobinuria, Paroxysmal, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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 20 Oct 2010. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224483, which also lists 3 linked publications.
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 20 Oct 2010.