Haemophilia B Clinical Trial
Official title:
An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients.
| NCT number | NCT02231944 |
| Other study ID # | R9VFSE |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | February 20, 2018 |
| Start date | July 1997 |
| Verified date | February 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To compare the first and second recovery assessments on Replenine®-VF and to evaluate
recovery of different batches if patients changed batches during the study.
To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | October 2003 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Previously treated patients - At least 12 years of age - Severe Haemophilia B and without inhibitor to factor IX Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Klinika Hematologii Instytutu Medycyny Wewnetrznej | Lodz | |
| Poland | Klinika Hematologii AM Lublin, ul.Jaczewskiego 8 | Lublin | |
| United Kingdom | Addenbrooke's Hospital, Hills Road | Cambridge | |
| United Kingdom | University Hospital of Wales, Heath Park | Cardiff | |
| United Kingdom | The Royal London Hospital | London | |
| United Kingdom | Manchester Royal Infirmary, Oxford Road | Manchester | |
| United Kingdom | Norwich and Norfolk Hospital | Norwich |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
Poland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later. | Safety assessments included: assessment of tolerance at injection site assessment of Factor IX inhibitor development assessment of frequency and type of adverse event routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable) screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches). |
Baseline and 3 months post-baseline. |
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