Trial Outcomes & Findings for Exjade-Early-Trial (NCT NCT01058369)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

within two years

Results posted on

2020-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Deferasirox Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Deferasirox Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Overall Study Adverse Event	1
Overall Study Early termination study	1

Baseline Characteristics

Exjade-Early-Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deferasirox n=2 Participants Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	42.5 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment Germany	2 participants n=93 Participants

PRIMARY outcome

Timeframe: within two years

Population: Trial prematurely ended due to insufficient recruitment before Primary endpoint was reached by any subject

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two years

Outcome measures

Outcome data not reported

Adverse Events

Deferasirox

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Deferasirox n=2 participants at risk Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Respiratory, thoracic and mediastinal disorders Pneumonia	50.0% 1/2 • Number of events 1
Blood and lymphatic system disorders acute myeloid leukaemia	50.0% 1/2 • Number of events 1

Other adverse events

Other adverse events
Measure	Deferasirox n=2 participants at risk Deferasirox (Novartis Pharma): Treatment period 102 weeks. Starting dose 10mg/kg/day. Up to 30/mg/kg according to dose adjustment table as specified in the protocol
Musculoskeletal and connective tissue disorders back pain	50.0% 1/2 • Number of events 1
Skin and subcutaneous tissue disorders petechiae	50.0% 1/2 • Number of events 1
Vascular disorders haematoma	50.0% 1/2 • Number of events 1
Vascular disorders thrombophlebitis	50.0% 1/2 • Number of events 1
General disorders fatigue	100.0% 2/2 • Number of events 2
Respiratory, thoracic and mediastinal disorders dyspnea	50.0% 1/2 • Number of events 1
Psychiatric disorders depression	50.0% 1/2 • Number of events 1
Injury, poisoning and procedural complications wound	50.0% 1/2 • Number of events 1
Gastrointestinal disorders nausea	50.0% 1/2 • Number of events 1
Gastrointestinal disorders dyspepsia	50.0% 1/2 • Number of events 1
Gastrointestinal disorders abdominal pain upper	50.0% 1/2 • Number of events 1
Vascular disorders hypertension	50.0% 1/2 • Number of events 1
Psychiatric disorders emotional distress	50.0% 1/2 • Number of events 1
Musculoskeletal and connective tissue disorders pain in extremity	50.0% 1/2 • Number of events 1
Vascular disorders gingival bleeding	50.0% 1/2 • Number of events 1

Additional Information

Prof. Dr. med. Stefan Krause

Universitätsklinikum Erlangen, Medizinische Klinik 5

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place