Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01091220
Status:
COMPLETED
Last Update Posted:
2011-09-05
First Post:
2010-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-02', 'studyFirstSubmitDate': '2010-03-19', 'studyFirstSubmitQcDate': '2010-03-22', 'lastUpdatePostDateStruct': {'date': '2011-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sperm motility (%)', 'timeFrame': 'baseline to 99 days'}, {'measure': 'Sperm morphology (%)', 'timeFrame': 'Baseline to 99 days'}], 'secondaryOutcomes': [{'measure': 'Progressive motility (%)', 'timeFrame': 'Baseline to 99 days'}, {'measure': 'Non-progressive motility (%)', 'timeFrame': 'Baseline to 99 days'}, {'measure': 'Sperm vitality (%)', 'timeFrame': 'Baseline to 99 days'}, {'measure': 'Semen volume (mL)', 'timeFrame': 'Baseline to 99 days'}, {'measure': 'Sperm count (millions)', 'timeFrame': 'Baseline to 99 days'}, {'measure': 'Sperm concentration (millions/mL)', 'timeFrame': 'Baseline to 99 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['certolizumab pegol', 'Cimzia®', 'healthy male volunteers', 'sperm'], 'conditions': ['Sperm Quality']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.', 'detailedDescription': "CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers with normal baseline semen quality parameters\n\nExclusion Criteria:\n\n* Previous participation in studies involving TNF inhibitors\n* Prior treatment with biologic response modifiers within 5 half-lives\n* History of trauma or surgery to the pelvis/genital area\n* Tests positive for tuberculosis, HIV, Hepatitis B or C'}, 'identificationModule': {'nctId': 'NCT01091220', 'briefTitle': 'Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'CR0001'}, 'secondaryIdInfos': [{'id': '2009-015216-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% saline', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Certolizumab pegol', 'description': 'Certolizumab pegol 400 mg', 'interventionNames': ['Biological: Certolizumab pegol']}], 'interventions': [{'name': 'Certolizumab pegol', 'type': 'BIOLOGICAL', 'otherNames': ['Cimzia®'], 'description': '400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously', 'armGroupLabels': ['Certolizumab pegol']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}