Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Factor VII | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color | ||
| Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content | ||
| Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of venous or arterial thrombosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Chapel Hill | North Carolina | 27599-7035 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17133240 | Result | Ashrani AA, Gabriel DA, Gajewski JL, Jacobs DR Jr, Weisdorf DJ, Key NS. Pilot study to test the efficacy and safety of activated recombinant factor VII (NovoSeven) in the treatment of refractory hemorrhagic cystitis following high-dose chemotherapy. Bone Marrow Transplant. 2006 Dec;38(12):825-8. doi: 10.1038/sj.bmt.1705535. No abstract available. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096722 | Cystitis, Hemorrhagic |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Chapel Hill |
| North Carolina |
| 27599-7400 |
| United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030-4009 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |