Trial · NCT00916656
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
NCT00916656, Phase 3, Withdrawn, CSL Behring
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fibrinogen Concentrate (Human) - Efficacy and Safety Study. Trials, record NCT00916656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00916656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fibrinogen Concentrate (Human) - Efficacy and Safety Study
- NCT number
- NCT00916656
- Status
- Withdrawn
- Phases
- Phase 3
- Enrollment
- 0 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Afibrinogenemia, Hypofibrinogenemia, Fibrinogen Deficiency
- Interventions
- Fibrinogen Concentrate, Human (FCH), Cryoprecipitate
- First posted
- 2009-06-09
- Last updated
- 2023-02-06
- Other registries' IDs
- eudract:2007-004088-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical assessment of hemostatic efficacy | 24 hours after last infusion or at Day 14 (whichever occurs first) | |
| Secondary | Maximum clot firmness (MCF) | Prior to and 60 minutes after the end of each infusion | |
| Secondary | Fibrinogen plasma level | 60 minutes, 3 hours, 6 hours, and 12 hours after the end of the first infusion; before and 60 minutes after each subsequent infusion | |
| Secondary | In vivo recovery of fibrinogen | 60 minutes, 3 hours, 6 hours and 12 hours after the end of the first infusion; before and 60 minutes after the end of each subsequent infusion and at the time of the overall clinical assessment of hemostatic efficacy | |
| Secondary | Virus safety markers | Day 1 to Day 45 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00916656
GET https://conductscience.org/api/trials/v1/NCT00916656/registered