NCT01631942|TerminatedPhase 1

Study Stopped

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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

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Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7415-39862011-005757-32U1111-1126-0327

Study Type

interventional

Target

Locations

5 countries

Sites

Timeline

RegisteredJun 2012

StartedJun 2012

CompletionSep 2012

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach

5 countries

6 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 months study duration

Study Start

First participant enrolled

June 26, 2012

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2012

Completed

Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

June 28, 2012

Last Update Submit

May 14, 2019

Conditions

Congenital Bleeding Disorder Haemophilia A Healthy

Outcome Measures

Primary Outcomes (1)

Number of adverse events (AEs)
From first trial drug administration through trial day 35

Secondary Outcomes (3)

Local tolerability
After the last s.c. dose administration (trial day 15)
Thrombocyte count
After the last s.c. dose administration (trial day 15)
Trough level (Ctrough)
Prior to the last s.c. dose administration (trial day 15)

Study Arms (3)

Low dose (healthy subjects)

EXPERIMENTAL

Drug: NNC172-2021

Medium dose (subjects with haemophilia)

EXPERIMENTAL

Drug: NNC172-2021

High dose (subjects with haemophilia)

EXPERIMENTAL

Drug: NNC172-2021

Interventions

NNC172-2021DRUG

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.

High dose (subjects with haemophilia)Low dose (healthy subjects)Medium dose (subjects with haemophilia)

Eligibility Criteria

Age18 Years - 64 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

You may not qualify if:

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

Contact the study team to confirm eligibility.