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NCT00411801
A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
Phase 3 trial testing Uniplas in Thrombotic Thrombocytopenic Purpura (TTP) in 8 participants. Terminated before completion.
1 February 2008
Quick facts
| Lead sponsor | Octapharma |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 May 2007 |
| Primary completion | 1 February 2008 |
| Estimated completion | 1 February 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Uniplas — full drug profile →
- Cryosupernatant plasma — full drug profile →
Conditions studied
- Thrombotic Thrombocytopenic Purpura (TTP) — all drugs for Thrombotic Thrombocytopenic Purpura (TTP) →
Sponsor
Octapharma — full company profile →
Who can join
18 and older, any sex, with Thrombotic Thrombocytopenic Purpura (TTP). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline in (log) platelet count 1 month after treatment initiation
Time frame: Baseline to Month 1
Log platelet count was reported in units, where 1 unit = 10\^9/L platelets.
Sponsor's own description
Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00411801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Thrombotic Thrombocytopenic Purpura (TTP)
Currently open trials in the same condition.
- NCT06441578 — A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura · recruiting
- NCT06945861 — Immunological Aspect of Thrombotic Thrombocytopenic Purpura (TTP) · recruiting
- NCT05714969 — A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombot · Phase 2 · active not recruiting
- NCT04683003 — A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura · Phase 3 · active not recruiting
Other Octapharma trials
Trials by the same sponsor.
- NCT06429787 — Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Antico · recruiting
- NCT05523297 — Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery · Phase 3 · completed
- NCT04918173 — Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery · Phase 3 · recruiting
- NCT04953884 — Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age · Phase 3 · completed
- NCT04508530 — Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00411801 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Octapharma
- Last refreshed: 19 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00411801.
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