Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

NCT01392547 | Completed Phase 3 Results

• 4 other identifiers: NN1731-35622010-023803-92U1111-1118-2228JapicCTI-111595
• Study Type: interventional
• Target: 72
• Locations: 19 countries
• Sites: 32

Brief Summary

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Conditions

Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (1)

• Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given

  Within 12 hours of first trial product administration

Secondary Outcomes (4)

• Effective and Sustained Bleeding Control

  Up to 48 hours after first trial product administration

• Number of Doses of Trial Product Given for Each Acute Bleed

  Up to 6 hours after first trial product administration

• Number of Adverse Events

  Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.

• Immunogenicity (Inhibitor Development)

  Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.

Study Arms (2)

rFVIIa

EXPERIMENTAL

Drug: eptacog alfa (activated)

vatreptocog alfa

EXPERIMENTAL

Drug: vatreptacog alfa (activated)

Interventions

vatreptacog alfa (activated) DRUG

1-3 doses per bleeding episode

vatreptocog alfa

eptacog alfa (activated) DRUG

1-3 doses per bleeding episode

rFVIIa

Eligibility Criteria

• Age: 12 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
• Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry

You may not qualify if:

• Previous participation in this trial defined as withdrawal after administration of trial product
• Patient has received an investigational medicinal product within 30 days prior to this trial
• Congenital or acquired coagulation disorders other than haemophilia A or B
• Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
• Platelet count of less than 50,000 platelets/mcL (at the screening visit)
• ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
• Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
• Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
• HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (32)

Novo Nordisk Clinical Trial Call Center

Tucson, Arizona, 85724-0001, United States

Location

Novo Nordisk Clinical Trial Call Center

Los Angeles, California, 90007, United States

Location

Novo Nordisk Clinical Trial Call Center

Los Angeles, California, 90027, United States

Location

Novo Nordisk Clinical Trial Call Center

Orange, California, 92868, United States

Location

Novo Nordisk Clinical Trial Call Center

Aurora, Colorado, 80045, United States

Location

Novo Nordisk Clinical Trial Call Center

Tampa, Florida, 33607, United States

Location

Novo Nordisk Clinical Trial Call Center

Atlanta, Georgia, 30322, United States

Location

Novo Nordisk Clinical Trial Call Center

Augusta, Georgia, 30912, United States

Location

Novo Nordisk Clinical Trial Call Center

Iowa City, Iowa, 52242, United States

Location

Novo Nordisk Clinical Trial Call Center

Boston, Massachusetts, 02115, United States

Location

Novo Nordisk Clinical Trial Call Center

Detroit, Michigan, 48202-2608, United States

Location

Novo Nordisk Clinical Trial Call Center

Brooklyn, New York, 11219, United States

Location

Novo Nordisk Clinical Trial Call Center

Portland, Oregon, 97239, United States

Location

Novo Nordisk Clinical Trial Call Center

Richmond, Virginia, 23219, United States

Location

Unknown Facility

Linz, A 4020, Austria

Location

Unknown Facility

Campinas, São Paulo, 13081970, Brazil

Location

Unknown Facility

Zagreb, 10 000, Croatia

Location

Unknown Facility

Athens, GR-11527, Greece

Location

Unknown Facility

Budapest, H-1134, Hungary

Location

Unknown Facility

Milan, 20124, Italy

Location

Unknown Facility

Shinjuku-ku, Tokyo, 160 0023, Japan

Location

Unknown Facility

Kuala Lumpur, 50400, Malaysia

Location

Unknown Facility

Warsaw, 02-776, Poland

Location

Novo Nordisk Clinical Trial Call Center

San Juan, 00935, Puerto Rico

Location

Unknown Facility

Timișoara, Timiș County, 300011, Romania

Location

Unknown Facility

Saint Petersburg, 191186, Russia

Location

Unknown Facility

Novi Sad, 21000, Serbia

Location

Unknown Facility

Parktown, Johannesburg, Gauteng, 2193, South Africa

Location

Unknown Facility

Changhua, 500, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Bornova-IZMIR, 35100, Turkey (Türkiye)

Location

Unknown Facility

Oxford, OX3 7LJ, United Kingdom

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

vatreptacog alfa; Factor VII

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 15, 2017
• Results First Posted: December 6, 2013

Record last verified: 2015-02

Locations

SE (1); AU (1); RO (1); GB (1); RU (1); ZA (1); HU (1); US (14); CR (1); GR (1); JP (1); PR (1); IT (1); PL (1); TW (1); TU (1); TH (1); BR (1); MY (1)