Información:
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ID
22468
Descripción
Study ID: 100273 Clinical Study ID: HS2100273 Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: valaciclovir Trade Name: ZELITREX,Valtrex,RAPIVIR,Novirus Study Indication: Herpes Genitalis Visit description: Screening
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Versiones (1)
- 5/6/17 5/6/17 -
Subido en
5 de junio de 2017
DOI
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Licencia
Creative Commons BY-NC 3.0
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Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Screening
Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Screening
Similar models
Efficacy of Valtrexin in Subjects with Recurrent HSV-2 Genital Herpes Screening
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C0011008 (UMLS CUI [1,1])
C0008952 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
Item
Check the boxes corresponding to any of the inclusion criteria the subject failed.
integer
C1512693 (UMLS CUI [1])
Code List
Check the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
Subject is in overall general good health. (1)
CL Item
Subject is a male or female who is 18 years of age or older. (2)
CL Item
A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal or surgically sterile); or child-bearing potential, has a negative pregnancy test (urine) at screen and agrees to one of the following: Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period of 1 week after study completion or premature discontinuation from the study (to account for elimination of the drug), Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, Implants of levonorgestrel, Injectable progestogen, Oral contraceptive (either combined or progestogen only), Any intrauterine device (IUD) with a documented failure rate of less than 1 % per year, Spermacide plus a mechanical barrier (condom/diaphragm) with a documented failure rate of less than 1 % per year. (3)
CL Item
Subject must have been previously diagnosed with HSV-2 genital herpes and have a history of at least 6 recurrences per year in the absence of suppressive antiherpetic therapy. Subject can enroll in the study as soon as three days (72 hours) after completing treatment for a recurrence. (4)
CL Item
Subject must be willing and able to provide written informed consent and comply with the protocol. (5)
CL Item
Subject must be HSV-2 seropositive at screening (6)
CL Item
Subject must have been previously diagnosed with HSV-2 genital herpes and have a history of at least 6 recurrences per year in the absence of suppressive antiherpetic therapy. Subject can enroll in the study as soon as three days (72 hours) after completing treatment for a recurrence. (4)
CL Item
Subject must be willing and able to provide written informed consent and comply with the protocol. (5)
CL Item
Subject must be HSV-2 seropositive at screening (6)
Item
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry
integer
C0680251 (UMLS CUI [1])
Code List
Check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry
CL Item
Subject is known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy, or chemotherapy for malignancy, or are seropositive for HIV). (1)
CL Item
Subject who previously received an investigational drug in the 30 days prior to the study. (2)
CL Item
Subject who previously received an investigational drug in the 30 days prior to the study. (2)
CL Item
Subject is receiving systemic antiviral or immunomodulatory treatments. Subjects must not have received systemic antiherpetic treatments (e.g., VALTREX®, Famvir®, acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug (3)
CL Item
Subject has clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit. Also, subjects with active liver disease are not acceptable for enrollment. (5)
CL Item
Subject is known to be hypersensitive to acyclovir, famciclovir or ganciclovir or any component of VALTREX formulations. (6)
CL Item
Subject has clinically significant impaired renal function as defined by creatinine clearance less than 30ml/min (calculated using the Cockcroft-Gault formula). (4)
CL Item
Subject has malabsorption or vomiting syndrome or other gastrointestional dysfunction that might impair drug pharmacokinetics. (8)
CL Item
Subject has clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit. Also, subjects with active liver disease are not acceptable for enrollment. (5)
CL Item
Women who are pregnant and/or nursing mothers. (10)
CL Item
Subjects with a current history of alcohol or drug abuse. (11)
CL Item
Subject is known to be hypersensitive to acyclovir, famciclovir or ganciclovir or any component of VALTREX formulations. (6)
CL Item
Subject is known to have an HSV infection that is resistant to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir. (7)
CL Item
Subject has malabsorption or vomiting syndrome or other gastrointestional dysfunction that might impair drug pharmacokinetics. (8)
CL Item
Women contemplating pregnancy within the duration of the study drug dosing period. (9)
CL Item
Women who are pregnant and/or nursing mothers. (10)
CL Item
Subjects with a current history of alcohol or drug abuse. (11)
Date sample taken
Item
Date sample taken
date
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
Item
Was a genital examination performed on the subject?
text
C0849001 (UMLS CUI [1])
C0849002 (UMLS CUI [2])
C0849002 (UMLS CUI [2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any other abnormal findings present?
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
CL Item
Yes (Y)
CL Item
No (N)
specify abnormal findings
Item
If Yes, specify:
text
C2826636 (UMLS CUI [1])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])
C0849001 (UMLS CUI [2,1])
C0849002 (UMLS CUI [2,2])