Condition category
Respiratory
Date applied
03/07/2008
Date assigned
10/07/2008
Last edited
31/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Stefanie Prante

ORCID ID

Contact details

Clinical Trial Manager
PARI Pharma GmbH
Steinerstrasse 15A
Munich
81369
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CLP 12011.202

Study information

Scientific title

A phase II, randomised, double-blind, placebo controlled, parallel group, dose-finding clinical trial to investigate the efficacy and safety of 10 and 20 mg/day aerosolised liposomal cyclosporin A (L-CsA) versus placebo in the treatment of bronchiolitis obliterans (BO) in allogeneic haematopoietic stem cell transplant (HSCT) patients

Acronym

L-CsA-HSCT

Study hypothesis

To established an investigational medicinal product (IMP) dosage with the most favourable risk-benefit ratio for the prevention of bronchiolitis obliterans (BO) in allogeneic haematopoietic stem cell transplant (HSCT) patients.

Please note that as of 31/07/2008 the sponsor details of this trial changed to PARI Pharma GmbH (Germany). The previous sponsor was Chiltern International (Germany).

As of 12/05/2009 this trial is on hold. The anticipated start and end dates have been amended; the initial trial dates were:
Anticipated start date: 01/11/2008
Anticipated end date: 01/01/2011

Ethics approval

Ethics approval pending as of 12/05/2009.

Study design

A phase II, multicentre, randomised, double-blind, placebo-controlled, parallel group, dose-finding clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bronchiolitis obliterans

Intervention

This trial was stopped as of 31/03/2010.

Subjects will be randomised (1:1:1) to one of three treatment arms:
1. 1 x 10 mg/day L-CsA and 1 x placebo/day
2. 2 x 10 mg/day L-CsA
3. 2 x placebo

Subjects will be stratified according to several baseline risk factors, e.g. myeloablative versus non-myeloablative regimen. Treatment duration will be 12 weeks with a 36 week follow-up period. After successful completion of the study, the patient may enter the follow-up clinical trial (ref: 12011.203) after fulfilling in/exclusion criteria.

Intervention type

Drug

Phase

Phase II

Drug names

Liposomal cyclosporin A (L-CsA)

Primary outcome measures

To establish an IMP dosage with the most favourable risk-benefit ratio for the prevention of BO in HSCT patients.

Secondary outcome measures

1. To compare efficacy and safety data from two different L-CsA doses versus placebo
2. To evaluate investigational medicinal product (IMP) pharmacokinetic (PK) data in bronchoalveolar lavage (BAL) and in whole blood samples

Overall trial start date

01/03/2010

Overall trial end date

01/12/2012

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

1. Signed informed consent provided prior to any screening procedure
2. Male or female, 12 years or older
3. Capable of self-administrating medications
4. Capable of understanding the purpose and risk of the study
5. Received an allogeneic haematopoietic stem cell transplantation
6. Has a diagnosis of bronchiolitis obliterans of grade 1, 2 or 3 based on forced expiratory volume in one second (FEV1) values according to protocol within one week prior to first investigational medicinal product administration (IMP)
7. Obtained a FEV1 value immediately before HSCT
8. Received within one week prior to first IMP administration the following immunosuppressive treatment and dosages for graft-versus-host-disease (GVHD) including bronchiolitis obliterans:
8.1. Tacrolimus 0.1 to 0.2 mg/kg/day adjusted to a target trough serum level (C0) of 5 to 15 µg/L
8.2. Prednisone 1 to 1.5 mg/kg/day for 2 to 6 weeks
9. Female patients with child bearing potential must have a negative serum pregnancy test within 3 days prior to screening. Both women and men must agree to use a medically-acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include intra-uterine device (IUD), oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository)
10. Estimated life expectancy greater than 6 months

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Has an active invasive bacterial, viral or fungal infection within one week prior to first IMP administration
2. Received systemic maintenance immunosuppressive therapy for GVHD other than listed in the inclusion criteria within one week prior to first IMP administration
3. Received any systemic or topical cyclosporin within one week prior to first IMP administration and/or during the clinical trial
4. Received mechanical ventilation
5. Pregnant or breast feeding woman
6. Has known hypersensitivity to cyclosporin A
7. Has a serum creatinine value of more than 3 mg/dL
8. Unlikely to comply with visits, inhalation procedures or spirometric measurements scheduled in the protocol
9. Receipt of an investigational drug as part of a clinical trial within four weeks prior to first administration of IMP
10. Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the subject's participation in the study
11. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
12. Has been previously enrolled in this study

Recruitment start date

01/03/2010

Recruitment end date

01/12/2012

Locations

Countries of recruitment

Austria, Belgium, Denmark, France, Germany, Switzerland, United Kingdom

Trial participating centre

Clinical Trial Manager
Munich
81369
Germany

Sponsor information

Organisation

PARI Pharma GmbH (Germany)

Sponsor details

Steinerstrasse 15A
Munich
81369
Germany

Sponsor type

Industry

Website

http://www.paripharma.com

Funders

Funder type

Industry

Funder name

PARI Pharma GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes