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1 Clinical Trial Details (PDF Generation Date :- Sat, 25 Aug :42:32 GMT) CTRI Number Last Modified On 23/07/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/ [Registered on: 19/01/2012] - Trial Registered Retrospectively No Interventional Drug Non-randomized, Multiple Arm Trial A clinical trial to study the effect of Isavuconazole in patients with Aspergillosis and Renal Impairment or of Patients with Invasive Fungal Disease Caused by Rare Molds, Yeasts or Dimorphic Fungi. Open Label Study of Isavuconazole in the Treatment of Patients with Aspergillosis and Renal Impairment or of Patients with Invasive Fungal Disease Caused by Rare Molds, Yeasts or Dimorphic Fungi. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NCT WSA-CS-003 Designation ClinicalTrials.gov Protocol Number Details of Principal Investigator Shoibal Mukherjee VP, Medical Affiliation Quintiles Research () Private Limited Phone Fax Designation Quintiles Research () Private Limited 8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana Quintiles Research () Private Limited 8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana Gurgaon HARYANA shoibal.mukherjee@quintiles.com Details Contact Person (Scientific Query) Dr Shoibal Mukherjee Vice President, Medical Affiliation Quintiles Research () Private Limited Phone Fax Designation 8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana Gurgaon HARYANA shoibal.mukherjee@quintiles.com Details Contact Person (Public Query) Suchela Srivatsa Director Clinical Operations Affiliation Quintiles Research () Private Limited page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax A-1, Leela Business Park MV Road, Andheri East, Mumbai Mumbai MAHARASHTRA Source of Monetary or Material Support > Astellas Pharma Global Development, Inc. (APGD) Type of Sponsor Quintiles Research Private Limited List of Countries Argentina Australia Belgium Brazil Canada Chile Egypt France Germany Italy Lebanon Mexico Poland Russian Federation South Africa Thailand United States of America of Principal Investigator Primary Sponsor Details Astellas Pharma Global Development Inc APGD Astellas Pharma Global Development, Inc. (APGD) Research & Development 3 Parkway North Deerfield, IL Pharmaceutical industry-global B , Shapath IV, Sarkhej-Gandhinagar Road, Ahmedabad , Gujarat of Site Site Phone/Fax/ Dr Pradyut Waghray Apollo Hospitals Sr. consultant, chest Physician, Apollo Hospitals, Jubilee Hills, Hyderabad , Andhra Pradesh, Hyderabad ANDHRA PRADESH Dr Melinkeri Sameer Ramesh Deenanath Mangeshkar Hospital and Research Centre Deenanath Mangeshkar Hospital and Research Centre pradyut_waghray@redif fmail.com docmelinkeri@gmail.co page 2 / 8

3 Details of Ethics Committee Dr Vijil Rahulan Global Hospitals & Health City Erandawane, Pune , Pune MAHARASHTRA Sr. Consultant & Incharge, center for critical care & Pulmonology, Global Hospitals & Health City, 439, Cheran Nagar, Perumbakkam, Chennai , Tamil Nadu, Chennai TAMIL NADU Dr Dipak Nayak Kasturba Hospital Proffessor and Head of department of ENT, Kasturba Hospital, Madhava Nagar, Manipal, , Karnataka Udupi KARNATAKA Dr Himanshu Garg Dr Apte Shashikant Janardan Medanta The Medicity Medanta The Medicity Sector-38,Gurgaon Haryana , Gurgaon HARYANA Sahyadri Speciality Hospital Sahyadri Speciality Hospital, 30 C, Erandawane, Karve Road, Pune , Pune MAHARASHTRA Dr J V Divatia Tata Memorial Hospital Professor & HOD of Anaesthesia, Critical Care & Pain Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai Mumbai MAHARASHTRA m vkrahulan@gmail.com nayakent@yahoo.co.in himanshu.garg@medan ta.org shashikant.apte@gmail. com jdivatia@vsnl.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Deenanath Mangeshkar Hospital Institutional Ethics Committee Pune Submittted/Under Review No Date Specified Ethics Committee Approved 28/01/2011 No Human Ethics Committee,Tata Memorial Hospital, Mumbai Institutional Ethics Committee Manipal University Ethics Committee Submittted/Under Review No Date Specified Yes Yes Approved 01/07/2011 No Approved 14/04/2011 Yes Medanta Independent Approved 18/05/2011 Yes page 3 / 8

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Ethics Committee Sahyadri Hospitals Limited Ethics Committee Status Approved 05/04/2011 No Date Approved/Obtained 18/07/2008 Health Type Patients Condition Aspergillosis and renal impairment or of patients with invasive fungal disease caused by rare molds, yeasts or dimorphic fungi. Type Details Intervention Isavuconazole Isavuconazole as intravenous (IV) infusion over at least one hour or oral therapy. Isavuconazole (BAL4815) is administered as a water soluble pro-drug Isavuconazonium sulphate (BAL8557). Throughout the protocol all doses of the pro-drug are expressed as the corresponding amount of active substance (isavuconazole). An isavuconazole loading regimen will be administered at approximately 8-hourly intervals during the first 48 hours followed by a maintenance dose from Day 3 onwards: hours: Three IV infusions or oral doses of 200 mg hours: Three IV infusions or oral doses of 200 mg - Day 3 to end of treatment (EOT): Maintenance dose of 200 mg IV or oral once daily Combination of isavuconazole with other systemic antifungals or change of dose is prohibited. Comparator Agent NA NA Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Male and female patients aged? 18 years at the time of signing the informed consent. Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons: - Postmenopausal for at least 1 year - Post-hysterectomy and/or post-bilateral ovariectomy - If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hcg) pregnancy test at screening and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for page 4 / 8

5 the purposes of this study. Patients who fall into one of the following 5 subgroups: a) Patients with proven, probable or possible invasive aspergillosis who have renal impairment, defined as calculated [Table 10] creatinine clearance (CLcr) enrollment who require primary therapy. NB: Patients fulfilling the criteria for possible invasive aspergillosis who also have renal impairment will be eligible for enrollment; however, diagnostic tests to confirm the invasive aspergillosis as probable or proven by culture, histology/cytology or galactomannan (GM) antigen must be completed within 7 days after the first administration of study medication. OR b) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) whether renally impaired or not who require primary therapy for their IFD at the time of enrollment as defined in the body of the protocol. OR c) Patients who have zygomycosis and require primary therapy are eligible for enrollment. Patients from the double-blinded WSA-CS-004 who had cultures positive for zygomycosis may discontinue blinded study drug and instead roll-over into WSA-CS-003 to complete primary therapy. OR d) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) who are refractory to current treatment defined as: clear documentation of progression of disease NB radiological progression only in association with WBC recovery is not Acceptable or failure to improve clinically despite currently receiving at least 7 days of standard antifungal regimen Prior to enrolling patients that fall into this category, please contact the Medical Monitor for approval. OR e) Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus fumigatus or Candida species) who are intolerant to current treatment defined as: doubling of serum creatinine value to higher than the upper limit of normal (ULN) within 48 hours or serum creatinine > 2.0 mg/ml and current treatment with polyene or IV voriconazole or other significant drug-related adverse reaction(s) to the current page 5 / 8

6 antifungal agent, resulting in discontinuation of the treatment, e.g. persistence of visual disturbance, allergic reaction, phototoxicity or severe infusion reaction (hypertensive crisis, severe chills or shock) or documented inability to achieve adequate blood levels of posaconazole. Exclusion Criteria Details Exclusion Criteria Women who are pregnant or breastfeeding. 2. Known history of allergy, hypersensitivity, or any serious reaction to the azole class of antifungals or to any component of the study medication. 3. Patients at high risk for QT/QTc prolongation such as: - Baseline prolongation of QTcF 500 msec - Risk factors for Torsade de Pointes (e.g. uncompensated heart failure, abnormal potassium or magnesium levels that cannot be corrected, any unstable cardiac condition during the last 30 days, or a family history of long QT syndrome); - The use of concomitant medications that prolong the QT/QTc interval (See Table 5 for examples). 4. Patients with evidence of hepatic dysfunction with any of the following abnormalities at the time of enrollment (may be re-checked using local laboratory): Total bilirubin 3 x upper limit of normal (ULN) OR Alanine transaminase or aspartate transaminase 5 x ULN OR Patients with known cirrhosis or chronic hepatic failure 5. Concomitant use of sirolimus, astemizole, cisapride, rifampin/rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, ritonavir, efavirenz, carbamazepine, pimozide, quinidine, neostigmine, terfenadine, ketoconazole, valproic acid or St. John s Wort in the 5 days prior to first administration of study medication. 6. Patients with either chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis (ABPA). 7. Microbiological findings (e.g. virological) or other potential conditions that are temporally related and suggest a different etiology for the clinical features in the absence of evidence of systemic fungal infection. 8. Advanced human immunodeficiency virus (HIV) infection with CD4 count 75 or uncontrolled acquired immunodeficiency syndrome-defining condition. 9. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy (e.g. neutropenia not expected to resolve or patients with fungal endocarditis). 10. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study. 11. Patients previously enrolled in a phase III study with ISA (NB page 6 / 8

7 patients may be transferred from study WSA-CS-004 if mycology identifies zygomycetes which is not expected to be susceptible to voriconazole). 12. Treatment with any investigational drug in any clinical trial 30 days prior to the first administration of study medication except open label protocols. 13. Patients who are unlikely to survive 30 days. 14. Patients with a body weight 40 kg. 15. Patients who need primary therapy for invasive aspergillosis who have been administered more than 4 cumulative days of itraconazole, voriconazole, or posaconazole, for any reason, within the 7 days prior to the first administration of study medication. Patients with applicable host factors who develop new evidence of IFD while on prophylactic therapy, for at least 14 days, with either an amphotericin B product or an echinocandin, will be eligible for enrollment. Prior use of fluconazole of any duration and any reason will be eligible for enrollment. 16. Patients currently on dialysis or likely to require dialysis during the administration of study medication. Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label Primary Outcome Outcome Timepoints Overall outcome of treatment (clinical, mycological and radiological response) evaluated by DRC at Day 42 Overall outcome of treatment (clinical, mycological and radiological response) evaluated by DRC at Day 42 Secondary Outcome Outcome Timepoints - Overall outcome of treatment evaluated by Investigator at Day 42 - Overall outcome at EOT and Day 84, assessed by DRC and Investigator - Clinical response at Days 42, EOT, Day 84 and FU, by DRC and Investigator - Mycological response at Day 42, EOT, Day 84 and FU, by DRC and Investigator - Survival rate at Days 42, 84, 120 and 180 Day42, 84, 120 and 180 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Total Sample Size=100 Sample Size from =30 01/01/ /01/2011 Years=0 Months=6 Days=0 page 7 / 8

8 Powered by TCPDF ( PDF of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Completed Completed NA This is an open label study of isavuconazole in the treatment of patients with aspergillosis and renal impairment or of patients with invasive fungal disease caused by rare molds, yeasts or dimorphic fungi. A total sample size of approximately 100 patients will be enrolled in the study. The final sample size may be increased or enrollment of patients with certain infections may be limited in order to enroll approximately 30 renally impaired patients with Invasive Aspergillosis, as well as adequate number of patients with proven zygomycosis. The overall outcome of treatment (clinical, mycological and radiological response) evaluated by DRC at Day 42. page 8 / 8