| CTRI Number |
CTRI/2021/04/033241 [Registered on: 29/04/2021] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to measure the long-term safety in patients with Cushing’s syndrome which are judged by the study doctor to benefit receiving the continued treatment of Osilodrostat drug. |
|
Scientific Title of Study
|
An open-label, multi-center, roll-over study to assess long term safety in
patients with endogenous Cushing’s syndrome who have completed a prior
Novartis-sponsored osilodrostat (LCI699) study and are judged by the
investigator to benefit from continued treatment with osilodrostat. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLCI699C2X01B Version 02 dated 06 May 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Suneela Thatte |
| Designation |
Vice President and Head, R and D Solutions |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Unit No. 902, 9th Floor, B Wing, Supreme Business Park
iranandani Gardens, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
2271097200 |
| Fax |
2266774343 |
| Email |
suneela.thatte@iqvia.com |
|
Details of Contact Person
Public Query
|
| Name |
Suneela Thatte |
| Designation |
Vice President and Head, R and D Solutions |
| Affiliation |
IQVIA RDS (India) Private Limited |
| Address |
Unit No. 902, 9th Floor, B Wing, Supreme Business Park
iranandani Gardens, Powai
Mumbai
MAHARASHTRA
400076
India |
| Phone |
2271097200 |
| Fax |
2266774343 |
| Email |
suneela.thatte@iqvia.com |
|
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Source of Monetary or Material Support
|
| RECORDATI AG
Lindenstrasse 8,
6340 Baar, Switzerland |
|
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Primary Sponsor
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| Name |
RECORDATI AG |
| Address |
Lindenstrasse 8,
6340 Baar, Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
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| Name |
Address |
| IQVIA RDSIndia Pvt Ltd |
Omega Embassy TechSquare,
Marathahalli-Sarjapur Outer Ring Road,
Kadubeesanahalli,
Bangalore – 560103 |
|
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Countries of Recruitment
|
Argentina
Austria
Belgium
Brazil
Bulgaria
Canada
China
Costa Rica
France
Germany
India
Italy
Japan
Netherlands
Poland
Republic of Korea
Russian Federation
Spain
Thailand
United States of America
Turkey |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Viveka P Jyotsna |
All India Institute of Medical Sciences |
Room No.: 58, DEXA
room, Ground Floor, Raj
Kumari Amrit KAur OPD Block, Ansari Nagar, New Delhi – 110029
New Delhi
DELHI |
1126546659
vivekapjyotsna@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E240||Pituitary-dependent Cushings disease, |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Osilodrostat |
Osilodrostat (LCI699) will be given in form of filmcoated
tablets for oral administration, and available in the following dose strengths: 1 mg, 5 mg and 10 mg. Patients will receive the same dose as the dose provided in the parent osilodrostat study at the time of transition to the roll-over study and for the entire duration of the study |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient is currently participating in a Global Novartis-sponsored study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
2. Patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
3. Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
4. Willingness and ability to comply with scheduled visits and treatment plans.
5. Written informed consent obtained prior to enrolling into the roll-over study before evaluating the applicability of the subject’s participating in the study.
5.1 If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness. |
|
| ExclusionCriteria |
| Details |
1. Patient has been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study.
2. Patients who are receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS.
3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory evaluation.
Pregnant or nursing (lactating) women
4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week of study after stopping medication. Highly effective contraception methods include
4.1 Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
4.2 Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation. at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
4.3 Male sterilization (at least 6 months prior to baseline). The vasectomized male partner should be the sole partner for that subject
4.4 Use of oral (estrogen and progesterone) injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1 percent), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study, treatment and must be used in combination with a barrier method (male condom).
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or total hysterectomy, or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, it will be considered not of childbearing potential. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate long term safety data |
30 days after last dose |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical benefit as assessed by the Investigator |
30 days after last dose |
|
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Target Sample Size
|
Total Sample Size="180"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= "127"
Final Enrollment numbers achieved (India)="1" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
02/05/2021 |
| Date of Study Completion (India) |
12/07/2023 |
| Date of First Enrollment (Global) |
05/10/2018 |
| Date of Study Completion (Global) |
16/11/2023 |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
Not applicable |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dear Sir/Mam, This is an ongoing
study recently transferred to IQVIA from new sponsor Recordati. The New Sponsor
Recordati has bought all the rights of Osilodrostat
(LCI699) from Novartis (earlier Novartis CTRI
Reg. no.: CTRI/2019/07/020063 [Registered on: 08/07/2019]. May we
request you to update the Date of first enrollment Global: 05 Oct 2018 and
India:15 Jul 2019 and India Recruitment status to completed.
The clinical study to evaluate long term safety in patients with
endogenous Cushing’s syndrome who have completed previous Novartis-sponsored
Osilodrostat (LCI699) drug study and are judged by the investigator to benefit
from continued treatment with Osilodrostat drug. |