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SNCTP000002955 | NCT03805477 | BASEC2018-00837

Nintedanib für Patienten mit Bronchiolitis obliterans nach Blutstammzell-Transplantation – eine multizentrische Phase 2 Studie

Data source: BASEC (Imported from 21.01.2021), WHO (Imported from 17.01.2021)
Changed: 14.01.2021
Disease category: Respiratory diseases (non cancer)

Brief description of trial (Data source: BASEC)

Unsere Studie wird an verschiedenen Standorten in der Schweiz durchgeführt. Insgesamt 40 Patienten werden in die Studie eingeschlossen. Die Studie ist eine „open-label“ Studie, das heisst, es ist bekannt, welches Medikament und in welcher Dosierung Sie einnehmen. Unsere Studie dauert insgesamt 12 Monate und beinhaltet gesamthaft 8 Studienvisiten.

Health conditions investigated (Data source: BASEC)

Diese Studie wird mit einem bereits von den Behörden zugelassenen Medikament durchgeführt. Dieses Medikament wird bereits zur Behandlung von Lungentumoren und Idiopathischer Lungenfibrose (stetig fortschreitende Vernarbung des Lungengewebes) eingesetzt und ist für diese Behandlung auch zugelassen.

Health conditions (Data source: WHO)

Bronchiolitis Obliterans Syndrome (BOS);Bronchiolitis Obliterans (BO)

Rare disease (Data source: BASEC)

Yes

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Das Medikament Nintedanib (Handelsname: Ofev) wird als Kapsel (150 mg) zweimal täglich (morgens und abends) eingenommen.

Interventions (Data source: WHO)

Drug: Nintedanib

Criteria for participation in trial (Data source: BASEC)

Sie sind älter als 18 Jahre und Sie leiden unter der Erkrankung „Bronchiolitis obliterans“ und Sie haben eine Blutstammzell-Transplantation vor weniger als fünf Jahren erhalten.

Exclusion criteria (Data source: BASEC)

Eine bekannte Unverträglichkeit auf den Wirkstoff Nintedanib
Sie sind schwanger oder stillen
Sie leiden oder litten innerhalb der letzten vier Wochen unter einer akuten Infektion der Atemwege
Sie benutzen Heimsauerstoff oder werden per Maske beatmet
Es ist Ihnen nicht möglich die wiederkehrenden Lungenfunktionstest durchzuführen.
Sie haben eine geringere Lebenserwartung als ein Jahr.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Time interval from transplant
- BOS as defined per the National Institute of Health (NIH) criteria:

1. FEV1/vital capacity < 0.7 or the fifth percentile of predicted.

2. FEV1 < 75% of predicted with = 10% decline over less than 2 years.

3. Absence of infection in the respiratory tract, documented with investigations
directed by clinical symptoms, such as chest radiographs, computed tomographic
(CT) scans, or microbiologic cultures (sinus aspiration, upper respiratory tract
viral screen, sputum culture, and broncho-alveolar lavage).

4. One of the 2 supporting features of BOS: 1. Evidence of air trapping by
expiratory CT or small airway thickening or bronchiectasis by high-resolution
chest CT, or 2. Evidence of air trapping by PFTs: residual volume > 120% of
predicted or residual volume/total lung capacity elevated outside the 90%
confidence interval and prior or current diagnosis of cGvHD per NIH criteria or
histologically proven BO

- Diagnosis of BOS within 6 months before enrollment or prior diagnosis of BOS with an
absolute decline of the percentage of predicted forced expiratory volume in 1 second
(FEV1) by >/= 10% within the past 12 months before inclusion

Exclusion Criteria

- Known intolerance to Nintedanib or any of its component

- Pregnancy or nursing

- Serum ALT > 5 x upper limit of normal (ULN) unless explained entirely by liver GvHD or
total bilirubin > 3x ULN unless explained entirely by liver GvHD

- Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before
study inclusion

- Chronic oxygen therapy; non-invasive ventilation

- Inability to give informed consent or to perform repeated pulmonary function tests
(PFT)

- Life expectancy < 1 year at the time of enrolment as suggested by the treating
physician

- Hematologic malignancy in hematologic relapse

- Symptomatic angina pectoris

- Therapeutic anticoagulation (primary or secondary prophylactic platelet
anti-aggregation allowed)

- Recent abdominal surgery or untreated gastric ulcer

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03805477

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03805477

Further information on trial

Date trial registered

08.01.2019

Incorporation of the first participant

20.03.2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

adverse event rate leading to interruption/ discontinuation of study treatment

Secundary end point (Data source: WHO)

overall survival;changes in Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) questionnaire;changes in NIH GvHD grading score;changes in St. George's Respiratory Questionnaire (SGRQ);disease-free survival of underlying hematologic disease;occurrence of GvHD in other organs;cumulative steroid doses;changes in in 6 minutes walking distance (6-MWD);Nitrogen (N2)-washout;Change in exhaled nitric oxide (eNO);Change in diffusion capacity of the lung for carbon monoxide (DLCO);change in total lung capacity (TLC);change in forced vital capacity (FVC);change of the percent of predicted forced expiratory volume in 1 second (FEV1)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel

Countries (Data source: WHO)

Austria, Germany, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

PD Dr. med. Katrin Hostettler Haack
+41 61 328 69 16
katrin.hostettler@usb.ch

Contact for general information (Data source: WHO)

Katrin Hostettler Haack, PD Dr. med
Clinic of Respiratory Medicine, University Hospital Basel
+41 61 328 69 16
Katrin.Hostettler@usb.ch

Contact for scientific information (Data source: WHO)

Katrin Hostettler Haack, PD Dr. med
Clinic of Respiratory Medicine, University Hospital Basel
+41 61 328 69 16
Katrin.Hostettler@usb.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

University Hospital, Basel, Switzerland

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

13.08.2018

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-00837

Secondary ID (Data source: WHO)

2018-00837
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