Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

October 11, 2021

Study Completion Date

November 3, 2021

Conditions
Beta-ThalassemiaNon-transfusion-dependent Thalassemia
Interventions
DRUG

VIT-2763 once a day (QD)

Participants will receive VIT-2763 QD at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.

DRUG

VIT-2763 twice a day (BID)

Participants will receive VIT-2763 BID at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.

DRUG

Placebo

Participants will receive hard capsules of Placebo, twice a day.

Trial Locations (16)

10043

Clinical Site #207, Orbassano

10700

Clinical Site #501, Bangkok

18411

Clinical Site #401, Afula

20122

Clinical Site #201, Milan

34362

Clinical Site #402, Haifa

37134

Clinical Site #202, Verona

49100

Clinical Site #403, Petah Tikva

50200

Clinical Site #502, Chiang Mai

54642

Clinical Site #303, Thessaloniki

65000

Clinical Site #503, Phitsanulok

80131

Clinical Site #203, Napoli

80138

Clinical Site #206, Napoli

90146

Clinical Site #205, Palermo

115 27

Clinical Site #301, Athens

265 04

Clinical Site #302, Rio

11-0236b

Clinical Site #101, Beirut

All Listed Sponsors
collaborator

Labcorp Corporation of America Holdings, Inc

INDUSTRY

lead

Vifor (International) Inc.

INDUSTRY

NCT04364269 - Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia | Biotech Hunter | Biotech Hunter