Trial Outcomes & Findings for DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment) (NCT NCT00664066)

Results Overview

This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.

Recruitment status

TERMINATED

Target enrollment

3 participants

Primary outcome timeframe

up to 3 years

Results posted on

2021-06-25

Participant Flow

This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.

The decision to enrol a subject was not to be made until after the decision on erythropoietin therapy had been made by the physician and drug had been prescribed. Physicians were to manage subjects according to their local practices and protocols.

Participant milestones

Participant milestones
Measure	Dynepo Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dynepo Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
Overall Study Study terminated	3

Baseline Characteristics

DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynepo n=3 Participants Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57.0 years FULL_RANGE 0.0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Germany	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 years

Population: This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.

This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.

Outcome measures

Outcome data not reported

Adverse Events

Dynepo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Publication restrictions are in place

Restriction type: OTHER