---
title: Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
nct_id: NCT01312636
overall_status: COMPLETED
sponsor: Novo Nordisk A/S
study_type: OBSERVATIONAL
primary_condition: Congenital Bleeding Disorder
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01312636.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01312636"
ct_last_update_post_date: 2014-10-20
last_seen_at: "2026-05-12T07:21:12.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

**Official Title:** A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients

**NCT ID:** [NCT01312636](https://clinicaltrials.gov/study/NCT01312636)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Novo Nordisk A/S
- **Conditions:** Congenital Bleeding Disorder, Congenital FVII Deficiency
- **Start Date:** 2011-03
- **Completion Date:** 2014-09
- **CT.gov Last Update:** 2014-10-20

## Brief Summary

This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Congenital FVII deficiency
* Never been treated with NovoSeven® before
* Patients already in treatment with NovoSeven®

Exclusion Criteria:

* History of hypersensitivity to any of the components in NovoSeven®
```

## Arms

- **A**

## Interventions

- **activated recombinant human factor VII** (DRUG) — Data will be collected at the baseline visit and approximately once a year until end of study.

## Primary Outcomes

- **Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions** _(time frame: once a year in years 1-4)_

## Secondary Outcomes

- **To assess the treatment evaluation for bleeding episodes** _(time frame: year 1, year 4)_
- **To assess the course and outcome of pregnancy in women treated with novoseven** _(time frame: until 1 month after giving birth)_

## Locations (1)

- Tokyo, Japan

## Recent Field Changes (last 30 days)

- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — 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.|tokyo||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01312636.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01312636*  
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