Trial · NCT04933968
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
NCT04933968, Phase 1, Phase 2, Terminated, AlloVir; results first posted 2024-06-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant. Trials, record NCT04933968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04933968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
- NCT number
- NCT04933968
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- AlloVir
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection, Influenza Infection
- Interventions
- ALVR106, Placebo
- First posted
- 2021-06-22
- Last updated
- 2024-06-06
- Results first posted
- 2024-06-06
- Limitations and caveats
- Results are included for Part A only as no participants were enrolled into Part B due to early study termination.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Day 1 up to 12 months | A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included new/worsening graft versus host disease, graft failure or rejection, cytokine release syndrome, infusion related reactions, new/worsening pneumonitis, and progressive dyspnea. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator. |
| Primary | Change in Viral Load From Baseline to Day 28 (Part B) | Baseline and Day 28 (Part B) | Change from Baseline in viral load as measured by quantitative PCR of nasal swab |
| Secondary | Identify the Recommended Phase 2 Dose (RP2D) (Part A) | Day 1 up to 12 months | The RP2D was to be determined after the maximum tolerated dose was reached in Part A. |
| Secondary | Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A) | Baseline and Day 28 | Viral load was measured by quantitative polymerase chain reaction (PCR) of nasal swab specimens. The cycle threshold value categorizes the concentration of viral genetic material in a participant's swab specimen, and the cycle threshold value represents the number of PCR cycles required to amplify the viral genetic material (as measured by fluorescence) to a detectable level that is distinguishable from baseline fluorescence, providing an estimate of viral load. Lower cycle threshold values indicate higher viral load and high values indicate lower viral load. A positive change from baseline indicates a decrease in the viral load. The baseline measurement was from a pre-dose nasal swab. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B) | Day 1 up to 12 months | |
| Secondary | Percentage Reduction in Viral Load From Baseline to Month 6 (Part B) | Day 1 and Month 6 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Day 1 up to 12 months | The safety population included all randomized participants who received any amount of ALVR106 or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Viral Load From Baseline to Day 28 (Part B) | Baseline and Day 28 (Part B) | No participants were enrolled into Part B due to the early termination of the study. | ||
| SECONDARY | Identify the Recommended Phase 2 Dose (RP2D) (Part A) | Day 1 up to 12 months | All randomized participants who received ALVR106 in Part A. | x 10^5 cells/kg | NUMBER |
| SECONDARY | Change in Viral Load Cycle Threshold From Baseline to Day 28 (Part A) | Baseline and Day 28 | The modified intent-to-treat population included all randomized participants who received any amount of ALVR106 or placebo and had confirmed virologic infection of interest at baseline (detectable viral load). Participants with baseline and Day 28 available data are included. | cycles | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part B) | Day 1 up to 12 months | No participants were enrolled into Part B due to the early termination of the study. | ||
| SECONDARY | Percentage Reduction in Viral Load From Baseline to Month 6 (Part B) | Day 1 and Month 6 | No participants were enrolled into Part B due to the early termination of the study. |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A: Placebo | Any TEAE | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 1: Dose A | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 2: Dose B | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 3: Dose C | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 4: Dose D | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A: Placebo | Any treatment-related TEAE | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 1: Dose A | Any treatment-related TEAE | 1 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 2: Dose B | Any treatment-related TEAE | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 3: Dose C | Any treatment-related TEAE | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Part A) | Part A ALVR106 Cohort 4: Dose D | Any treatment-related TEAE | 0 | Participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: Placebo | 3 | |
| Overall Study | STARTED | Part A ALVR106 Cohort 1: Dose A | 3 | |
| Overall Study | STARTED | Part A ALVR106 Cohort 2: Dose B | 4 | |
| Overall Study | STARTED | Part A ALVR106 Cohort 3: Dose C | 4 | |
| Overall Study | STARTED | Part A ALVR106 Cohort 4: Dose D | 3 | |
| Overall Study | STARTED | Part B Expansion Cohort | 0 | |
| Overall Study | COMPLETED | Part A: Placebo | 0 | |
| Overall Study | COMPLETED | Part A ALVR106 Cohort 1: Dose A | 0 | |
| Overall Study | COMPLETED | Part A ALVR106 Cohort 2: Dose B | 0 | |
| Overall Study | COMPLETED | Part A ALVR106 Cohort 3: Dose C | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events615
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Part A: Placebo | 1 | 2 | |
| other | COVID-19 | Infections and infestations | Part A ALVR106 Cohort 1: Dose A | 0 | 3 | |
| other | COVID-19 | Infections and infestations | Part A ALVR106 Cohort 2: Dose B | 3 | 4 | |
| other | COVID-19 | Infections and infestations | Part A ALVR106 Cohort 3: Dose C | 0 | 4 | |
| other | COVID-19 | Infections and infestations | Part A ALVR106 Cohort 4: Dose D | 0 | 3 | |
| other | Sepsis | Infections and infestations | Part A: Placebo | 0 | 2 | |
| other | Sepsis | Infections and infestations | Part A ALVR106 Cohort 1: Dose A | 0 | 3 | |
| other | Sepsis | Infections and infestations | Part A ALVR106 Cohort 2: Dose B | 0 | 4 | |
| other | Sepsis | Infections and infestations | Part A ALVR106 Cohort 3: Dose C | 1 | 4 | |
| other | Sepsis | Infections and infestations | Part A ALVR106 Cohort 4: Dose D | 0 | 3 |
1 to 10 of 615Source ClinicalTrials.gov
See all 615 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Placebo | 0 | 2 |
| Total, all-cause mortality | Part A ALVR106 Cohort 1: Dose A | 0 | 3 |
| Total, all-cause mortality | Part A ALVR106 Cohort 2: Dose B | 2 | 4 |
| Total, all-cause mortality | Part A ALVR106 Cohort 3: Dose C | 2 | 4 |
| Total, all-cause mortality | Part A ALVR106 Cohort 4: Dose D | 0 | 3 |
| Total, other adverse events | Part A: Placebo | 2 | 2 |
| Total, other adverse events | Part A ALVR106 Cohort 1: Dose A | 3 | 3 |
| Total, other adverse events | Part A ALVR106 Cohort 2: Dose B | 4 | 4 |
| Total, other adverse events | Part A ALVR106 Cohort 3: Dose C | 4 | 4 |
| Total, other adverse events | Part A ALVR106 Cohort 4: Dose D | 3 | 3 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04933968
GET https://conductscience.org/api/trials/v1/NCT04933968/results?page=2