A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects (explorer™2)
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ClinicalTrials.gov Identifier: NCT01631942 |
Recruitment Status :
Terminated
(See detailed description)
First Posted : June 29, 2012
Last Update Posted : May 15, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Bleeding Disorder Haemophilia A Healthy | Drug: NNC172-2021 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects |
Actual Study Start Date : | June 26, 2012 |
Actual Primary Completion Date : | September 4, 2012 |
Actual Study Completion Date : | September 4, 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Low dose (healthy subjects) |
Drug: NNC172-2021
Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation. |
Experimental: Medium dose (subjects with haemophilia) |
Drug: NNC172-2021
Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation. |
Experimental: High dose (subjects with haemophilia) |
Drug: NNC172-2021
Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation. |
- Number of adverse events (AEs) [ Time Frame: From first trial drug administration through trial day 35 ]
- Local tolerability [ Time Frame: After the last s.c. dose administration (trial day 15) ]
- Thrombocyte count [ Time Frame: After the last s.c. dose administration (trial day 15) ]
- Trough level (Ctrough) [ Time Frame: Prior to the last s.c. dose administration (trial day 15) ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors
Exclusion Criteria:
- Known or suspected hypersensitivity to trial product(s) or related products
- Thrombocyte count below the lower limit of normal range at screening
- Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631942
Austria | |
Novo Nordisk Investigational Site | |
Wien, Austria, 1090 | |
France | |
Novo Nordisk Investigational Site | |
Lyon, France, 69003 | |
Novo Nordisk Investigational Site | |
Montpellier, France, 34295 | |
Germany | |
Novo Nordisk Investigational Site | |
Berlin, Germany, 10249 | |
Spain | |
Novo Nordisk Investigational Site | |
Madrid, Spain, 28046 | |
United Kingdom | |
Novo Nordisk Investigational Site | |
Harrow, United Kingdom, HA1 3UJ |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01631942 |
Other Study ID Numbers: |
NN7415-3986 2011-005757-32 ( EudraCT Number ) U1111-1126-0327 ( Other Identifier: WHO ) |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | May 15, 2019 |
Last Verified: | May 2019 |
Hemostatic Disorders Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Vascular Diseases Cardiovascular Diseases |