Kliinilise uuringu otsus nr RKU-4/40

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

18.06.2024 nr RKU-4/40

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor Intercept Pharmaceuticals Inc., keda käesolevas menetluses esindab Syneos

Health Latvia, esitas 02.05.2024 Ravimiametile taotluse ravimi kliinilise uuringu teostamiseks

määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse (RavS) § 991 lõikes 1 sätestatud

tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel

anda uuringu sponsorile Intercept Pharmaceuticals Inc. loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr 747-213 järgmistel tingimustel:

uuringuplaani number: 747-213 (versioon 6 kuupäevaga 31. oktoober 2023)

uuringu referentsnumber: 19-043

uuringu nimetus: „A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating

the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with

Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response

or Who Were Unable to Tolerate Ursodeoxycholic Acid“

uuringu sponsor: Intercept Pharmaceuticals Inc.

uuritavate arv Eestis: 2

vastutavad uurijad ja uuringukeskused:

- Dr Riina Salupere, Tartu Ülikooli Kliinikum, L. Puusepa tn 8, 50406 Tartu, Eesti

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Olga Siperkovska

Syneos Health Latvia

Krisjana Valdemara Street 21-11

LV-1010, Riia

LÄTI

2 (2)

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

18.06.2024 nr RKU-4/40

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor Intercept

Pharmaceuticals Inc. on 02.05.2024 to conduct a clinical trial under the conditions stipulated

in Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act

(MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no 747-213 under the following conditions:

protocol no: 747-213 (Version 6, dated October 31, 2023)

full title of the trial: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating

the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with

Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response

or Who Were Unable to Tolerate Ursodeoxycholic Acid

sponsor of the trial: Intercept Pharmaceuticals Inc.

number of subjects in Estonia: 2

principal investigators and study locations:

- Dr Riina Salupere, Tartu University Hospital, L. Puusepa tn 8, 50406 Tartu, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

Olga Siperkovska

Syneos Health Latvia

Krisjana Valdemara Street 21-11

LV-1010, Riga

LATVIA

2 (2)

(digitally signed)

Katrin Kiisk

Director General