GOOD MORNING AND WELCOME. The International Liver Congress Berlin, April 2011
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1 GOOD MORNING AND WELCOME The International Liver Congress Berlin, April 2011
2 INTRODUCTION AND AIMS
3 PROTOCOL OVERVIEW, CRF AND OTHER FORMS
4 PROTOCOL OVERVIEW: INCLUSION CRITERIA HBsAg + antihdv + 18 years old (?) >6 months signed informed consent IDEALLY 1000 PATS. IN THE FIRST 2 YEARS 300 PATS./YEAR THEREAFTER
5 PROTOCOL OVERVIEW: EXCLUSION CRITERIA Any cause of relevant liver disease other than HDV.
6 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA
7 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA
8 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA
9 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
10 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
11 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
12 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
13 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
14 PROTOCOL OVERVIEW: PROCEDURES ALL INCLUSION CRITERIA NO EXCLUSION CRITERIA +
15 PROTOCOL OVERVIEW: PROCEDURES +
16 PROTOCOL OVERVIEW: PROCEDURES +
17 PROTOCOL OVERVIEW: PROCEDURES +
18 HDV? PROTOCOL OVERVIEW: PROCEDURES +
19 HDV? PROTOCOL OVERVIEW: PROCEDURES HBV vaccination! +
20 HDV? PROTOCOL OVERVIEW: PROCEDURES HBsAg? antihdv? HBV vaccination! +
21 HDV!! PROTOCOL OVERVIEW: PROCEDURES HBsAg? antihdv? HBV vaccination! +
22 PATIENT FORM 1. Information for the patients Updated medical history What is hepatitis delta and where to find more information Healthy liver tips
23 PATIENT FORM 1. Information for the patients Updated medical history What is hepatitis delta and where to find more information Healthy liver tips 2. Information for other health professionals What is hepatitis delta? Special measures they should take Where to find more information about HDV
24 PATIENT FORM 1. Information for the patients Updated medical history What is hepatitis delta and where to find more information Healthy liver tips 2. Information for other health professionals What is hepatitis delta? Special measures they should take Where to find more information about HDV 3. Double check the patient s data
25 CENTRE FORM 1. Overview of all the patients they have included 2. Identification of typos and inconsistencies
26 CASE REPORT FORM: CRF SCREENING FORM Patient number Date Diagnosis of chronic Hepatitis D: month-year /estimation Diagnosis of chronic Hepatitis B: month-year /estimation Informed consent given, discussed and signed; date Presence of a medical condition associated with chronic liver disease Organ transplantation with an existing functional graft PATIENT DATA Sex Height Weight Country of birth Are there any HDV infected relatives? PREVIOUS ANTIVIRAL THERAPIES Total number Therapy 1: IFN / pegifn / nucleo(t)sides / others Therapy 1: dates Therapy 1 : Side effects CONCOMITANT CONDITIONS Cirrhosis? Previous Decompensation: date, type (ascites, liver encephalopathy, esophageal bleeding) grade Diabetes? Dialysis? Alcohol intake? Pregnant? Other diagnosis, date, intensity Concomitant medications: Name; dosis, start date
27 CASE REPORT FORM: CRF HEMATOLOGY Hemoglobin Leucocytes Neutrophils Thrombocytes COAGULATION: INR OTHER AFP AMA, ANA PBMCs available? BIOCHEMISTRY ALT / GPT AST / GOT GGT Bilirrubin total Alkaline phosphatase Protein total Albumin BUN Creatinine Sodium Cholinesterin Creatinine clearance VIROLOGY antihav IgG antihav IgM antihcv HCV-RNA antihiv HBsAg qual. and quant. antihbs HBeAg antihbe HBV-DNA qual. and quant. antihdv HDV RNA qual. and quant.
28 CASE REPORT FORM: CRF LIVER BIOPSY Date Score (Ishak) Grading and staging Frozen liver tissue available? TRANSIENT ELASTOGRAPHY Date Elasticity Variability USG Date Spleen length Spleen diameter Liver steatosis Ascites Liver nodules ARFI: date; result ENDOSCOPY: date; esophageal varices grade
29 GOALS AND DEADLINES Unlimited Duration of follow up Number of recruited patients Interim analysis: 500 patients enrolled/ 1 year after day 1 Once yearly thereafter
30 Management issues Ethics Data privacy Database; Hannover Clinical Trial Center (HCTC)
31 PATIENT INFORMATION AND INFORMED CONSENT (i) Ethics and data privacy 1) Ethics: depending on the local ethic guidelines we will soon have an approval from MHH s ethics commission
32 PATIENT INFORMATION AND INFORMED CONSENT (i) Ethics and data privacy 1) Ethics: depending on the local ethic guidelines we will soon have an approval from MHH s ethics commission MHH English,German first language You Herewith I confirm, that our patient information and informed consent are translated properly Yes, I have sent back the translated documents
33 PATIENT INFORMATION AND INFORMED CONSENT (ii) In general: documents should be in accordance with the local standard
34 PATIENT INFORMATION AND INFORMED CONSENT (ii) In general: documents should be in accordance with the local standard Data privacy: depending on the local data protection law location of the database is Germany = Datenschutzgesetz Ethics: also dependend on the local ethic rules; we will have a ethic vote from the mainly responsible ethics commission
35 PATIENT INFORMATION AND INFORMED CONSENT (ii) In general: documents should be in accordance with the local standard Data privacy: depending on the local data protection law location of the database is Germany = Datenschutzgesetz Ethics: also dependend on the local ethic rules; we will have an approvation from the mainly responsible ethics commission You are in charge of getting in touch with the local ethics commission Send back the translated form + a retranslation in English
36 BLINDING: PATIENT CODE country centre patient
37 BLINDING: PATIENT CODE country centre patient e.g. Patient number 5 in Medizinische Hochschule Hannover (Germany) Germany
38 BLINDING: PATIENT CODE country centre patient e.g. Patient number 5 in Medizinische Hochschule Hannover (Germany) Germany MHH
39 BLINDING: PATIENT CODE country centre patient e.g. Patient number 5 in Medizinische Hochschule Hannover (Germany) Germany MHH Patient number 5
40 BLINDING: PATIENT CODE country centre patient e.g. Patient number 5 in Medizinische Hochschule Hannover (Germany)
41
42 MHH Prof.Dr. M.Manns Prof.Dr. H.Wedemeyer Dep. Gastroenterology Deutsche Leberstiftung (German Liver Foundation) Competence Network Hepatitis Hep-Net e.v.
43 MHH Prof.Dr. M.Manns Prof.Dr. H.Wedemeyer Dep. Gastroenterology HCTC Prof.Dr. H. von der Leyen Deutsche Leberstiftung (German Liver Foundation) Competence Network Hepatitis Hep-Net e.v.
44 MHH Prof.Dr. M.Manns Prof.Dr. H.Wedemeyer Dep. Gastroenterology HCTC Prof.Dr. H. von der Leyen Deutsche Leberstiftung (German Liver Foundation) Competence Network Hepatitis Hep-Net e.v.
45 HCTC: Central Mangement Organisation for Clinical Trials: cost-effective academic CRO cooperating with medical facility Hannover Medical School (MHH) suited in the middle of a complex network of top level partners
46 HCTC: Central Mangement Organisation for Clinical Trials: Study set-up: Scientific advice Regulatory support Clinical trial application Operational management: Project management Monitoring Data management and collection Biometric evaluation: in cooperation with Div. of Biometry at MHH Pharmacovigilance: in cooperation with Clinical Pharmacology at MHH
47 MARVIN Integrated eclinical application integrates numerous functions from the areas of EDC (Electronic Data Capture) DDE (Double Data Entry) CDM (Clinical Data Management) CTM (Clinical Trial Management) Patient Reported Outcome (epro) into one data base Features: intuitive smooth data entry and query management No specific soft- and hardware requirements (except DSL/ISDN) Online reports, pdf print-outs
48 ecrf: Marvin
49 The DELTA website
50 Potential collaboration projects
51 Thank you!
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