Review of the Fialuridine (FIAU) Clinical Trials (1995) / Chapter Skim
Currently Skimming:
Appendix D: Informed Consent Documents
Appendix D: Informed Consent Documents
Pages 184-243
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 184... ...
PPPA (New England Medical Center, Boston)
|
From page 185... ...
If ~ agree to be in this study the for lowing will be done: 1. I wil ~ have a complete history, physical exam, viral cultures, and blood drawn for laboratory tests at the time of enrollment, and at least every other week thereafter for up to 12 weeks.
|
From page 186... ...
If I have not been taking AZT previously, ~ understand that I cannot start AZT until after the 12 week study period.
|
From page 187... ...
for identification. Study records may be reviewed by the AIDS Clinical Trials Coordinating Center, the NIAID, Oclassen Pharmaceuticals, or the U.S.
|
From page 188... ...
If you have cues.ions regarding a research study, the researcher or his/her assistant will be g, ad to answer them. You may seek info~i`,ation from the Human Subjects Committee - established 'or the protection of Volunteers in research projects - by calling (619)
|
From page 191... ...
Standard blood tests, urinalysis, s~cal cue, 2C, 2.~l, HS'~I, ~Z~ and/or HB~ (heca~i~ s 3 virus) tests, eye exams, c -- KG, 2nd tests measuring the conc~nc~ation of FIAT in your clocd alit 1 He cone an some of these vis its .
|
From page 192... ...
You should also understand that the investigators of ~c.his study are requesting ye: ur permission to review your medical records for purposes of this research study. The medical records utilized 192
|
From page 193... ...
T understand =.-ac i' I withdraw, the invest 'gaffers will retain access to my study data and any stored specimens. ~ was given an occortunitv to ask questions arid understand that future questions I rev nave abacus A
|
From page 194... ...
At the screening and baseline visits you wit 1 have blood drawn for AIDS virus and immune functi on tests as well as for routine blood tests (four tablesoc'ans )
|
From page 195... ...
Standard blood tests, urinalysis, stoo ~ guaiac, hepatitis B virus (HB;I) tests, EKG, and tests measuring the concentration of FIAU in your blood will be done at some of these visits.
|
From page 196... ...
If you are a woman, you must avo id pregnancy while taxing this drug, and, if you are sexually active, you must agree to use some four of barrier contraception whir e you participate and for at least 3 months following study completion. If you are a woman of child-bearing potential, you wit..
|
From page 197... ...
These samples will be identified only by code number and will be accessible e only to studies involving current Univers ity of Washington investigators . The study drug, FIAT, laboratory tests, and clinic visits will be provided free of charge .
|
From page 199... ...
I '~ill have a complete history, physical exam, viral cultures, and bloac! drawn For laboratory tests at the time o f en-oliment, and on at least 3 days over a period of 2 weeks .
|
From page 200... ...
ganc~c~ov~r, roscarnet, or Interferon Curing the study. If hare not been taking AZT previously, I understand the cannot start AZT until after the 2 week study period.
|
From page 201... ...
Study and other medical records may be reviewed by the AIDS Cl intact Trials Coordinating Center, the NTATO, Oclassen Pharmaceuticals, or the U
|
From page 202... ...
If you have questions regarding a research s~udy, th~ researcher or his/her assistant will be glad to answer them. You may seek in'o_~.ation from the Human Subjects Commit~ee - established for the protection of ~rolur.tee~s in research projects - by callins (619)
|
From page 204... ...
whichever comes first. Even if FIAU ap~,cars safe and capable of suppressing herpes group or hepatitis R vines infections we cannot give Ante `,f it to you until the :1 and Drug Ad~ninistrations a~,pr<'ves o'er doing s<, P A T IF f~ t IDE to I lFlC^l ION CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY · Adult Patient or · Parent for Minor Patient 204
|
From page 205... ...
in indivicluals Silo are otherwise tile Me, belt clo not have chronic hepatitis.
|
From page 206... ...
If you have chronic hepatitis B virus infection, we will e.xa~tline you briefly in clinic and c~btai', additional blooc! santpIes at days 21 (I week post treatment)
|
From page 207... ...
MEDICAL flECOf~t) | CONTINUATION SHEET for either: NIH 2514-1, Consent to Participate In ~ Clinical Research Study NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study STUDY NUMBER: CONTINUATION: page 4 of 6 pages.
|
From page 208... ...
Second, it is conceivable that wI,at we learn about FJAU may provide us simpler and more effective ways of treating CMV infections. Third, should you be treated for chronic HElV infection, we may identify ~ ding dint could benefit your infection.
|
From page 209... ...
ol l'.."CI.9,`1~' ~ n.lIP s.~t,-~ f rJl Ir~f rl t Ir ICA'r lorJ S o'`al~l'~ ot `~.ln<3ss ~ t) ale S~5ned CONSENT TO PARTICIPATE tN A CLINICAL RESEARCH STUDY ~ Adult Patierit or · P?
|
From page 211... ...
you are invited to take part in this research study designed to test the medication FTAU for its effect on your liver disease. The full name of FlAU is I-2' deoxy-2, f~uoro-~-beta-Darabinofuranosyl-5-iodo-uracil.
|
From page 212... ...
of hepatitis virus infection. These studies will include multiple blood tests, a urine analysis, and a 24-hour urine collection, a chest X-ray and electrocardiogram (heart tracing)
|
From page 213... ...
(6) After treatment you will be seen in the clinic for brief visits and to have blood drawn every one to two months until Six months after starting FlAD when you will have a thorough evaluation in the outpatient clinic which will include a medical history, a physical examination, multiple blood tests and a urine test.
|
From page 214... ...
At the time of the liver biopsy you will be given a more complete and detailed consent form that outlines how the liver biopsy is done and its complications.
|
From page 215... ...
Drugs similar to FlAU may lower the number of red blood cells, making some patients Aridly anemic, or lower the number of white blood cells, which make up your immune system, thereby making you more susceptible to infections. However, you are unlikely to develop a serious infection because we will stop treatment if the white blood ce]
|
From page 216... ...
spechy re~t~onsn~p) Signature of Investigator ~ Date Signed PATIENT IDENTIFICATION Signature of Witness ~ Date Sines CONSENT TO PARTICIPATE tN A CLINICAL RESEARCH STUDY · Adult Patient or · Parent, for Minor Patient 216
|
From page 217... ...
Date (If Other than Parent' Specify Relationship) Signature of Witness Date INFORMED CONSENT STATEMENT FOR HIV BLOOD TESTING NIH 2663 (2~9)
|
From page 219... ...
As a patient with chronic hepatitis B you are invited to take part in this research study designed to test FIAU for its effect on your liver disease.
|
From page 220... ...
These studies Will include multiple blood tests and a urine analysis. One blood test that you will have is for antibody to the human immunodeficiencY virus (anti-~IV)
|
From page 221... ...
M.nor Patient s Assent to Pan~c~pate In A Clinical Research Study STUDY NUMBER: 93-DK-31 CONTINUATION: page 3 of 6 pages.
|
From page 222... ...
Drugs similar to flAU may lower the number of red blood cells, making some patients mildly anemic, or lower the number of white blood cells, which make up your immune system, thereby making you more susceptible to infections. However, you are unlikely to develop a serious infection because we will stop treatment the white blood cell count falls too low.
|
From page 223... ...
~ ~ i ' ~ ~ ~ : ~ ~ i ~ r i ~ ~ ~ i I i ;- L MEDICAL RECORD GONTINUATtOtY SHEET for aNher: NIH 251~. Consent to Panicipase ln A Clinical Research Study N1H 251~2.
|
From page 224... ...
Same CONSENT TO PARTICIPATE IN A C! ItilCAL RESEARCH STUDY (Continuation Shot)
|
From page 226... ...
(AIDSIHIV, hepatitis C, hepatitis D) ; LOW blood count rests, Bad anthrax, ~mmuno~o~c, car other investigational Snag therapy within the last sit: months; Advanced cirrhosis an liver biopsy or significant Aver disease other than hepatitis B; Any Ever function tests that do not meet entry requirements; Abnormal fly function; Abused aicoho!
|
From page 227... ...
Me Day 2S, Month 2 and Month 3 visits wall involve ~ physical examination, current assessment of my symptoms, blood rest and a unne test, until ~ finish talking my stucly medication ~ - 11 then have a visit to the doctor's office every 3 months. One year after ~ have completed study Unug therapy ~ will have a liver biopsy; if my lab ten's show that ~ have riot benefited from the study drug, my physician mI!
|
From page 228... ...
These side effects include anerrua (abnonnally low number of red blood cells in the bloodstream) , changes in laboratory tests that measure Ever' honey, and muscle function, stomach pain, nausea, vomiting, headache, fatigue, and muscle aches.
|
From page 229... ...
AL=RN~41IVE ~ERAP=.S As an altematwe to p~iapation in this study, ~ understan~l that mterforon is approved by the FDA for the treatment of chronic HEV infection ~ understand that I could choose this drug rather than participate in As research study.
|
From page 230... ...
Paar with the study records and that I will receive a signed copy of this fornL A copy of the signed consent form will be sent to the sponsor. 'A _ S=ature of Subject Subject Name (Pnnted)
|
From page 232... ...
~ Your doctor has explained to you that you have chronic hepatitis B| purpose of this Study is to determine whether two cliff Brent dos ,F7AU given at different intervals for 90 days are effactive~ in -~4 Or eliminating the hepatitis B virus. You will be for '~d fly years after you stop taking the medication if you benefit from the |drug or f or 1 year at ter you stop taicing the medication if tests show sufficient improvement.
|
From page 233... ...
Kaplan, AD P 3/3 i you have previously been evaluated, and the results of your exa3iia~ · and Laboratory values indicate that you bare Chronic hepatitis A, .~ you do meet all the entry requirements required to enroll it thig stud j Approximately one week before beginning treatment, you willit~va a~l_~e~ I biopsy if you have notepad a liver biopsy, that we can Aced, within .~ Apart year.
|
From page 234... ...
PIAy id ·4 I weir investigational drug taken for 14 to 28 days By 54 p7~.ient~ ! chronic hepatitis B
|
From page 235... ...
. ~ ~th'~ beau Parke caper ~n ~~s research study.
|
From page 236... ...
at Company and I wil t receive a copy. L 'nuers~ane that as a participant in this study by identity and by ::ei'ic61 records and data relating to this research study~i:~l be kept co~fidsntia4.
|
From page 238... ...
PROCEDURES Before entering the study you were interviewed by a physician who asked about your medical history and completed a general physical examination. In addition, you have had blood and urine tests done, a heart tracing performed, and may have had a chest x-ray performed if you had not had one within the last six months.
|
From page 239... ...
FL\U is a new investigational drug taken for 14 to 28 days by 54 parents with chronic hepatitis B An additional 100 patients have been treated for up to ~ weeks with a similar drug, FIAC, that is turned into FIAU in humans.
|
From page 240... ...
· Advanced cirrhosis on liver biopsy or significant liver disease. · Abused alcohol or drugs within the preceding 6 months.
|
From page 241... ...
If any important new information is found during this study that may affect your wanting to continue to be part of this study, you will be told about it. CONFIDENTIALITY If you agree to participate in this study, the information obtained will be shared with Eli Lilly and Company, the United States Food and Drug Administration, and similar agencies in other countries, all of whom may look at your medical records.
|
From page 242... ...
I understand that I may freely stop being a part of this study at any time. I have received a copy of this informed consent form to keep for myself.
|
From page 243... ...
Protocol H3X-LC-PPPG(a) Page 6 of 6 ~0 FIDE Fialur~dine (LY303256~: Bioequ~valence of Syrup and Tablet Formulations, and Influence of Tiering of Meals on Pharmacokinetic Variables You will be paid $25.00 for each day you participate in this study.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.