DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
62	発作性夜間ヘモグロビン尿症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-002128-10-DE (EUCTR)	14/03/2017	24/10/2016	A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria	An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of crovalimab in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)	Paroxysmal nocturnal hemoglobinuria (PNH) MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Product Code: RO7112689/F01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-01 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230 Product Code: RO7112689/F03-03 INN or Proposed INN: Not available Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	49	Phase 1;Phase 2	France;Hungary;Netherlands;Germany;Italy;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002128-10-DE
(EUCTR)

14/03/2017

24/10/2016

A Study to Assess Safety, Effectiveness, Pharmacokinetics, and Pharmacodynamics of crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria

An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of crovalimab in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)

Paroxysmal nocturnal hemoglobinuria (PNH)
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Code: RO7112689/F01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Code: RO7112689/F03-01
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230
Product Code: RO7112689/F03-03
INN or Proposed INN: Not available
Other descriptive name: C5 inh MAb, SKY59, RO/CH7092230

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 2

France;Hungary;Netherlands;Germany;Italy;Japan;Korea, Republic of