---
title: Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
nct_id: NCT01561924
overall_status: COMPLETED
phase: PHASE1
sponsor: Novo Nordisk A/S
study_type: INTERVENTIONAL
primary_condition: Congenital Bleeding Disorder
countries: United States, Denmark, France, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01561924.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01561924"
ct_last_update_post_date: 2016-11-23
last_seen_at: "2026-05-12T06:11:14.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography

**Official Title:** An Exploratory Non-interventional Study of Ex-vivo Spiking Followed by Thromboelastography as a Method for Predicting the Efficacy of Recombinant Activated Human FVII (rFVIIa, NovoSeven®) in Adult Congenital Haemophilia A or B Patients With Inhibitors

**NCT ID:** [NCT01561924](https://clinicaltrials.gov/study/NCT01561924)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** Novo Nordisk A/S
- **Conditions:** Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- **Start Date:** 2005-11
- **Completion Date:** 2006-05
- **CT.gov Last Update:** 2016-11-23

## Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the basal and spiked TEG® (Thromboelastography) or ROTEM® (Thromboelastometry) profiles of frequently bleeding haemophilia subjects with inhibitors in a non-bleeding state.

## Detailed Description

The TEG parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT)

## Eligibility

- **Minimum age:** 16 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C clot activity or FIX:C clot activity, respectively, less than 5%
* Presently use of activated recombinant human factor VII (NovoSeven®) as haemostatic agent for preventive treatment or treatment of bleeding episodes
* A documented historical or present record for the presence of inhibitors to factor VIII or IX, respectively
* A documented history of 2 or more joint bleeding episodes during the preceding 12 months
* Subjects must be in a non-bleeding state (i.e. no clinical manifestations of active bleeds)

Exclusion Criteria:

* Subjects who have received any haemostatic treatment for a bleeding episode within the last 7 days prior to this trial
* Immune tolerance therapy within the last 30 days prior to this trial
* Clinically relevant coagulation disorders other than congenital haemophilia A or B
* Thrombocytopenia (platelet count below 60,000 platelets/mcl)
* Prophylactic haemostatic treatment within 3 days prior to this trial
```

## Arms

- **Ex vivo** (EXPERIMENTAL)

## Interventions

- **eptacog alfa (activated)** (DRUG) — Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.

## Primary Outcomes

- **TEG parameters obtained at baseline and with activated recombinant human factor VII**
- **ROTEM parameters obtained at baseline and with activated recombinant human factor VII**

## Locations (7)

- Novo Nordisk Investigational Site, Berkeley, California, United States
- Novo Nordisk Investigational Site, Los Angeles, California, United States
- Novo Nordisk Investigational Site, Iowa City, Iowa, United States
- Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, United States
- Novo Nordisk Investigational Site, Århus N, Denmark
- Novo Nordisk Investigational Site, Lyon, France
- Novo Nordisk Investigational Site, London, United Kingdom

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|berkeley|california|united states` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|los angeles|california|united states` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|iowa city|iowa|united states` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|århus n||denmark` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|lyon||france` — added _(2026-05-12)_
- `locations.novo nordisk investigational site|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01561924.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01561924*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*