Cytomegalovirus InfectionsPhase 2NCT01753167
A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
A Phase 2 study testing MCMV3068A and MCMV5322A in people with Cytomegalovirus Infections, run by Genentech, Inc. at 39 sites in 8 countries.
Trial summary
This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- MCMV3068A and MCMV5322A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 14 Dec 2012to 15 Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is scheduled to receive a primary or secondary renal allograft from a donor
- Participant is seronegative for CMV and is receiving an allograft from a CMV-seropositive donor
- Female participants of child-bearing age must have a negative pregnancy test result on Day 1, prior to infusion
- For women who are not postmenopausal or surgically sterile (defined as absence of ovaries and/or uterus): agreement to remain completely abstinent or use two methods of contraception at all times
Who cannot join
- Participant is suspected of having CMV disease
- Participant has received anti-CMV therapy within the 30 days prior to screening (exceptions are the use of acyclovir, valacyclovir, or famciclovir for up to 10 days duration for treatment of acute herpes simplex or herpes zoster or participants receiving acyclovir or valacyclovir at doses to suppress herpes zoster)
- Participants who have received intravenous immunoglobulin (IVIG) within 3 months before transplantation or with expectation of receiving IVIG at time of transplantation or in the 3 months after transplantation
- Participants who have received B cell-depleting therapies (including but not limited to rituximab) within 3 months before transplantation or with the expectation of receiving such therapy at the time of transplantation or in the 3 months after transplantation
- Participant is receiving a multi-organ transplant (e.g., liver or pancreas in addition to kidney)
- Active or chronic hepatic or hepatobiliary disease (including known Gilbert's syndrome) or elevations in a hepatic transaminase or bilirubin >= 2 times upper limits of normal (ULN)
Show all 15Show fewer
- Participant is unlikely or unwilling to be available for follow-up for the full 24-week duration of the study
- Female participants who are pregnant, plan to become pregnant during the study, or who are breastfeeding
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins or human-derived immunoglobulin preparations; or any constituent of MCMV5322A/MCMV3068A or placebo
- Active treatment for untreated tuberculosis or other infectious conditions that are significant in the judgment of the investigator
- Infection with hepatitis B, hepatitis C or human immunodeficiency virus
- Previous exposure to any investigational agent within 12 weeks or 5 half-lives
- Any other acute or chronic condition, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the Principal Investigator, contraindicates the use of an investigational drug or that may affect the interpretation of the results or that renders the participant at high risk for treatment complications
- History of alcoholism or substance abuse within 6 months before screening
- Participant is expected to require treatment or prophylaxis with an antiviral with anti-CMV activity during the study
Trial locations and contacts
39 sites in 8 countries.
39 sites in 8 countries
United States15 sites
Emory University
Atlanta, Georgia, 30322
Georgia Regents University
Augusta, Georgia, 30912
Erie County Medical Center; Dept. of Nephrology
Buffalo, New York, 14215
University of Cincinnati / University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
Baylor Univ Medical Center
Dallas, Texas, 75246
University of Colorado Health Sciences Center; Dept of Medicine
Denver, Colorado, 80262
Henry Ford Health System; Gastroenterology
Detroit, Michigan, 48202-2689
UCLA; Kidney & Pancreas Transplantation
Los Angeles, California, 90095
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
California Inst. of Renal Research
San Diego, California, 92123
Univ of CA San Francisco; Kidney Transplant Service
San Francisco, California, 94143-0780
Washington Uni School of Medicine/Barnes Jewish Hospital; Renal
St Louis, Missouri, 63110
Georgetown Uni Hospital; Division of Transplant Surgery
Washington D.C., District of Columbia, 20007
MedStar Washington Hosp Center
Washington D.C., District of Columbia, 20010
France6 sites
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, 33076
CHU de Nantes; Institut de transplantation urologie-néphrologie
Nantes, 44093
Hopital Necker
Paris, 75743
Hopital Rangueil; Gastro Enterologie Et Nutrition
Toulouse, 31059
Chu De Tours
Tours, 37000
Hopitaux De Brabois; Nephrologie
Vandœuvre-lès-Nancy, 54511
Spain5 sites
Fundació Puigvert
Barcelona, Barcelona, 08025
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
CEIC del Hospital Virgen del Rocío
Seville, Sevilla, 41013
Germany4 sites
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
Dresden, 01307
Universitätsklinikum Essen Zentrum f.Innere Medizin Abt.Nephrologie
Essen, 45122
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik III
Frankfurt, 60596
Uniklinikum Heidelberg
Heidelberg, 69120
Belgium3 sites
Clin Univ de Bxl Hôpital Erasme
Brussels, 1070
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
Sweden3 sites
Sahlgrenska Universitetssjukhuset; Jubileumskliniken
Gothenburg, 413 45
Karolinska University Hospital
Huddinge, 141 86
Akademiska Sjukhuset; Transplantation Surgery
Uppsala, 751 85
United Kingdom2 sites
Royal Free Hospital
London, NW3 2QS
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
About this study
Official title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients
This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).
- Conditions
- Cytomegalovirus Infections
- Being tested
- MCMV3068A, MCMV5322A, Placebo
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCMV3068ADrug
Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
MCMV5322ADrug
Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
PlaceboDrug
Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
| Study group | Role | What they receive |
|---|---|---|
| MCMV5322A/MCMV3068A | Experimental | Participants will receive a total of four doses of study drug administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. MCMV5322A/MCMV3068A will be tested in this study at 10 milligrams per kilogram (mg/kg) of each component antibody. Thus, at each dose, 10 mg/kg of MCMV5322A and 10 mg/kg of MCMV3068A will be tested (20 mg/kg total). Receives: Drug: MCMV3068A; Drug: MCMV5322A |
| Placebo | Placebo comparator | Participants will receive a total of four doses of placebo matched with MCMV5322A/MCMV3068A administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events
Measured: Baseline up to Week 24
Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) During the First 12 Weeks After Transplantation
Measured: Baseline up to Week 12
Secondary outcomes (12)
Percentage of Participants With CMV Viral Load >= 150 Copies/mL During the First 24 Weeks After Transplantation
Measured: Baseline up to Week 24
Time to Detectable CMV Viral Load >=150 Copies/mL
Measured: Baseline up to Week 24
Viral Load at the First Detection of CMV DNAemia (>=150 Copies/mL), DNAemia is detection of deoxyribonucleic acid (DNA)
Measured: Baseline up to Week 24
Peak Viral Load on or Following First Detection of CMV DNAemia (>=150 Copies/mL)
Measured: Baseline up to Week 24
Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation
Measured: Baseline up to Weeks 12 and 24
Time to Initiation of First use of Preemptive Antiviral Therapy
Measured: Baseline up to Week 24
Duration of First use of Preemptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation
Measured: Baseline up to Weeks 12 and 24
Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation
Measured: Baseline up to Week 24
Percentage of Participants With Change in CMV Serostatus
Measured: Baseline up to Week 24
MCMV5322A Serum Concentrations
Measured: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
MCMV3068A Serum Concentrations
Measured: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to MCMV5322A and MCMV3068A
Measured: Predose (0 hours) on Days 1, 29, 57; at Days 85, 113, and 141; and at Study Completion (Day 169)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start14 Dec 2012
- Primary completion15 Oct 2014
- Study completion15 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753167
- Sponsor's protocol ID
- GV28418
- Other IDs
- 2012-002245-37
- Status last verified
- Mar 2017
- First submitted
- 17 Dec 2012
- Last updated
- 8 Mar 2017
- Results posted
- No
Publications
Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
PubMed 39807668Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
PubMed 38700045Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.
PubMed 29133549Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.
PubMed 27872061
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-blind, Placebo-controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients
- ClinicalTrials.gov ID
- NCT01753167
- Acronym / sponsor ID
- GV28418
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2012 (actual)
- Primary completion
- 15 Oct 2014 (actual)
- Study completion
- 15 Oct 2014 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCMV5322A/MCMV3068A | Experimental | Drug: MCMV3068A, Drug: MCMV5322AParticipants will receive a total of four doses of study drug administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. MCMV5322A/MCMV3068A will be tested in this study at 10 milligrams per kilogram (mg/kg) of each component antibody. Thus, at each dose, 10 mg/kg of MCMV5322A and 10 mg/kg of MCMV3068A will be tested (20 mg/kg total). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a total of four doses of placebo matched with MCMV5322A/MCMV3068A administered by intravenous infusion: at the time of transplantation (Day 1), and at Days 8, 29, and 57. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is scheduled to receive a primary or secondary renal allograft from a donor
- Participant is seronegative for CMV and is receiving an allograft from a CMV-seropositive donor
- Female participants of child-bearing age must have a negative pregnancy test result on Day 1, prior to infusion
- For women who are not postmenopausal or surgically sterile (defined as absence of ovaries and/or uterus): agreement to remain completely abstinent or use two methods of contraception at all times
Key exclusion criteria (15 listed)
- Participant is suspected of having CMV disease
- Participant has received anti-CMV therapy within the 30 days prior to screening (exceptions are the use of acyclovir, valacyclovir, or famciclovir for up to 10 days duration for treatment of acute herpes simplex or herpes zoster or participants receiving acyclovir or valacyclovir at doses to suppress herpes zoster)
- Participants who have received intravenous immunoglobulin (IVIG) within 3 months before transplantation or with expectation of receiving IVIG at time of transplantation or in the 3 months after transplantation
- Participants who have received B cell-depleting therapies (including but not limited to rituximab) within 3 months before transplantation or with the expectation of receiving such therapy at the time of transplantation or in the 3 months after transplantation
- Participant is receiving a multi-organ transplant (e.g., liver or pancreas in addition to kidney)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCMV3068AFour doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. | Drug | MCMV5322A/MCMV3068A |
| MCMV5322AFour doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. | Drug | MCMV5322A/MCMV3068A |
| PlaceboFour doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57. | Drug | Placebo |
Primary outcome
Percentage of Participants With Adverse Events
Time frame: Baseline up to Week 24
Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) During the First 12 Weeks After Transplantation
Time frame: Baseline up to Week 12
12 secondary outcomes
Percentage of Participants With CMV Viral Load >= 150 Copies/mL During the First 24 Weeks After Transplantation
Time frame: Baseline up to Week 24
Time to Detectable CMV Viral Load >=150 Copies/mL
Time frame: Baseline up to Week 24
Viral Load at the First Detection of CMV DNAemia (>=150 Copies/mL), DNAemia is detection of deoxyribonucleic acid (DNA)
Time frame: Baseline up to Week 24
Peak Viral Load on or Following First Detection of CMV DNAemia (>=150 Copies/mL)
Time frame: Baseline up to Week 24
Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation
Time frame: Baseline up to Weeks 12 and 24
Time to Initiation of First use of Preemptive Antiviral Therapy
Time frame: Baseline up to Week 24
Duration of First use of Preemptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation
Time frame: Baseline up to Weeks 12 and 24
Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation
Time frame: Baseline up to Week 24
Percentage of Participants With Change in CMV Serostatus
Time frame: Baseline up to Week 24
MCMV5322A Serum Concentrations
Time frame: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
MCMV3068A Serum Concentrations
Time frame: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to MCMV5322A and MCMV3068A
Time frame: Predose (0 hours) on Days 1, 29, 57; at Days 85, 113, and 141; and at Study Completion (Day 169)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Derived from this study: PubMed 39807668Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.
- Derived from this study: PubMed 38700045Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.
- Derived from this study: PubMed 29133549Deng R, Wang Y, Maia M, Burgess T, McBride JM, Liao XC, Tavel JA, Hanley WD. Pharmacokinetics and Exposure-Response Analysis of RG7667, a Combination of Two Anticytomegalovirus Monoclonal Antibodies, in a Phase 2a Randomized Trial To Prevent Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2018 Jan 25;62(2):e01108-17. doi: 10.1128/AAC.01108-17. Print 2018 Feb.
- Derived from this study: PubMed 27872061Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e01794-16. doi: 10.1128/AAC.01794-16. Print 2017 Feb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
39 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MCMV3068A and MCMV5322A in people with Cytomegalovirus Infections, run by Genentech, Inc. at 39 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, France, Spain, Germany, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (time frame: Baseline up to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753167, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.